Eastman Kodak Company
Rochester, NY, US
EASTMAN KODAK COMPANY appears in FDA device records in Rochester, NY. FDA records list 291 510(k) clearances between and , 5 PMA records and 5 registered establishments. As of , FDA records show 95 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Eastman Kodak Company carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Carestream Health, Inc.registration, 510(k), PMA, enforcement report, recall
510(k) clearance history
Showing 50 of 291FDA records hold 291 510(k) clearances for Eastman Kodak Company between 1977 and 2026. The busiest year on record is 1992, with 28. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 6 |
| 1978 | 1 |
| 1979 | 3 |
| 1980 | 14 |
| 1981 | 9 |
| 1982 | 4 |
| 1983 | 6 |
| 1984 | 9 |
| 1985 | 3 |
| 1986 | 16 |
| 1987 | 11 |
| 1988 | 15 |
| 1989 | 16 |
| 1990 | 14 |
| 1991 | 19 |
| 1992 | 28 |
| 1993 | 9 |
| 1994 | 14 |
| 1995 | 3 |
| 1996 | 4 |
| 1997 | 7 |
| 1998 | 5 |
| 1999 | 1 |
| 2000 | 2 |
| 2001 | 2 |
| 2002 | 3 |
| 2003 | 2 |
| 2004 | 5 |
| 2005 | 2 |
| 2006 | 5 |
| 2008 | 2 |
| 2009 | 4 |
| 2011 | 4 |
| 2012 | 4 |
| 2013 | 2 |
| 2014 | 3 |
| 2015 | 6 |
| 2016 | 3 |
| 2017 | 3 |
| 2018 | 4 |
| 2019 | 5 |
| 2020 | 4 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 1 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253185 | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System | IZL | Substantially Equivalent | |
| K250954 | DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector | KPR | Substantially Equivalent | |
| K251168 | Image Suite | LLZ | Substantially Equivalent | |
| K241505 | DRX-Revolution Mobile X-ray System | IZL | Substantially Equivalent | |
| K233381 | DRX-Evolution Plus System | KPR | Substantially Equivalent | |
| K223842 | DRX - Compass | KPR | Substantially Equivalent | |
| K213568 | DRX-Rise Mobile X-ray System | IZL | Substantially Equivalent | |
| K213307 | Eclipse II with Smart Noise Cancellation | MQB | Substantially Equivalent | |
| K202441 | Eclipse II with Smart Noise Cancellation | MQB | Substantially Equivalent | |
| K203159 | Lux 35 Detector | MQB | Substantially Equivalent | |
| K201373 | DRX-Compass | KPR | Substantially Equivalent | |
| K192894 | Vita Flex CR System with LLI | MQB | Substantially Equivalent | |
| K193574 | Q-Rad System | KPR | Substantially Equivalent | |
| K191879 | DRX-Evolution with Carestream Digital Tomosynthesis | KPR | Substantially Equivalent | |
| K190330 | DRX-Evolution/Plus with Dual Energy | KPR | Substantially Equivalent | |
| K191025 | DRX-Revolution Mobile X-ray System | IZL | Substantially Equivalent | |
| K183245 | Carestream DRX-1 System with DRX Plus 2530 Detectors | MQB | Substantially Equivalent | |
| K183474 | Carestream DRX-1 System with DRX Core Detectors | MQB | Substantially Equivalent | |
| K180809 | Eclipse II | MQB | Substantially Equivalent | |
| K180667 | SmartGrid | MQB | Substantially Equivalent | |
| K173924 | DRX-Revolution Nano Mobile X-ray System | IZL | Substantially Equivalent | |
| K173478 | OnSight 3D Extremity System | JAK | Substantially Equivalent | |
| K170755 | DRX-Revolution Nano Mobile X-ray System | IZL | Substantially Equivalent | |
| K170580 | Carestream Vue PACS | LLZ | Substantially Equivalent | |
| K163157 | SmartGrid | MQB | Substantially Equivalent | |
| K163203 | Carestream DRX-Evolution | KPR | Substantially Equivalent | |
| K160723 | OnSight 3D Extremity System | JAK | Substantially Equivalent | |
| K153103 | CARESTREAM Vue PACS | LLZ | Substantially Equivalent | |
| K152467 | Touch Ultrasound | IYN | Substantially Equivalent | |
| K153142 | Carestream DRX-1 System with DRX Plus 4343 Detectors | MQB | Substantially Equivalent | |
| K151774 | CARESTREAM Vue Motion | LLZ | Substantially Equivalent | |
| K150766 | Carestream DRX-1 System | MQB | Substantially Equivalent | |
| K150342 | Touch Ultrasound | IYO | Substantially Equivalent | |
| K141837 | DRX-EVOLUTION | KPR | Substantially Equivalent | |
| K140271 | TABLET VIEWER SOFTWARE FOR IMAGE SUITE | LLZ | Substantially Equivalent | |
| K133442 | BONE SUPPRESSION SOFTWARE | MQB | Substantially Equivalent | |
| K132824 | CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION | LLZ | Substantially Equivalent | |
| K130567 | DR LONG LENGTH IMAGING SOFTWARE | MQB | Substantially Equivalent | |
| K130464 | CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR | MQB | Substantially Equivalent | |
| K122523 | CARESTREAM VUE PACS | LLZ | Substantially Equivalent | |
| K120246 | KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN) | MUE | Substantially Equivalent | |
| K120062 | DRX-REVOLUTION MOBILE X-RAY SYSTEM | IZL | Substantially Equivalent | |
| K111423 | CS 1600 INTRAORAL CAMERA | NBL | Substantially Equivalent | |
| K112321 | CS 1200 | EIA | Substantially Equivalent | |
| K110919 | CARESTREAM PACS | LLZ | Substantially Equivalent | |
| K111566 | DRYVIEW CHROMA IMAGING SYSTEM | LMC | Substantially Equivalent | |
| K111649 | CS 7600 | MUH | Substantially Equivalent | |
| K091186 | KODAK 1500 INTRAORAL CAMERA | EIA | Substantially Equivalent | |
| K091889 | DRX-EVOLUTION, MODEL VX3733-SYS | KPR | Substantially Equivalent | |
| K090469 | CARESTREAM DRYVIEW 5850 LASER IMAGER | LMC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3015532525 | 3015532525 | CARESTREAM HEALTH, INC. | 882 Linden Ave., Rochester, NY 14625 US | 2026 | |
| 1317307 | 1317307 | Carestream Health, Inc | 1049 West Ridge Road, Rochester, NY 14615 US | 2026 | and 3 more, listed in full below |
| 1317267 | 1317267 | Carestream Health, Inc. | 1669 Lake Avenue, Rochester, NY 14652 US | 2026 | |
| 3029911 | 1000524463 | Carestream Health, Inc. | 8124 Pacific Ave, WHITE CITY, OR 97503 US | 2026 | |
| 3038430126 | 3038430126 | EASTMAN KODAK COMPANY | 318 Technology Blvd., Rochester, NY 14652 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CED5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase
- IYEAccelerator, Linear, Medical
- CKEAcid Phosphatase, Thymolphthale Inmonophosphate
- CIDAlizarin Sulfonate, Calcium
- CGXAlkaline Picrate, Colorimetry, Creatinine
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- GTYAntigens, All Groups, Streptococcus Spp.
- GTZAntisera, All Groups, Streptococcus Spp.
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- IXACassette, Radiographic Film
- INNChair, Adjustable, Mechanical
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- JHYColorimetric Method, Cpk Or Isoenzymes
- DIHColorimetry, Cholinesterase
- DKJColorimetry, Salicylate
- CHSCoulometric Method, Carbon-Dioxide
- IXLDevice, Spot-Film
- CIGDiazo Colorimetry, Bilirubin
- JHSDifferential Rate Kinetic Method, Cpk Or Isoenzymes
- DIFDrug Mixture Control Materials
- CEMElectrode, Ion Specific, Potassium
- JGSElectrode, Ion Specific, Sodium
- CHTElectrophoretic Method, Catecholamines
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- DMTEnzymatic Method, Alcohol Dehydrogenase, Ultraviolet
- JFYEnzymatic Method, Creatinine
- DIPEnzyme Immunoassay, Diphenylhydantoin
- IWZFilm, Radiographic
- JIHFlame Photometry, Lithium
- IXJGrid, Radiographic
- GCJLaparoscope, General & Plastic Surgery
- FCWLight Source, Fiberoptic, Routine
- FCSLight, Catheter, Fiberoptic, Glass, Ureteral
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CHILipase-Esterase, Enzymatic, Photometric, Lipase
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JIDPhotometric Method, Ammonia
- JIYPhotometric Method, Iron (Non-Heme)
- JGJPhotometric Method, Magnesium
- IXWProcessor, Radiographic-Film, Automatic
- CGIRadioimmunoassay, Estriol
- CECRadioimmunoassay, Free Thyroxine
- CFTRadioimmunoassay, Prolactin (Lactogen)
- CDPRadioimmunoassay, Total Triiodothyronine
- EAMScreen, Intensifying, Radiographic
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- CIWStarch-Dye Bound Polymer, Amylase
- FZMStool, Operating-Room
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- IZISystem, X-Ray, Angiographic
- JACSystem, X-Ray, Film Marking, Radiographic
- IZLSystem, X-Ray, Mobile
- JAKSystem, X-Ray, Tomography, Computed
- IZZTable, Radiographic, Non-Tilting, Powered
- EIAUnit, Operative Dental
- EHDUnit, X-Ray, Extraoral With Timer
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
Showing 25 of 95| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0289-2024 | The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. the system consists of a self-contained x-ray generator, image receptor(s), imaging display and software for acquiring medical diagnostic images outside of standard stationary x-ray room. The DRX-Revolution system incorporates a flat-panel detector that can be used wirelessly for exams such as in-bed chest projections. The system can also be used to expose CR phosphor screens or films. | There is a potential for unexpected failure of the electrical components within the Carestream Health Inc. generator installed in your DRX-Revolution Mobile X-ray System(s). This can lead to temporary and self contained thermal overload within the generator. Should an event like this occur, the system will become inoperable and loud noise, burnt smell and smoke may be detectable. | Class II | Open, Classified | |
| Z-0437-2024 | DRX Revolution Mobile X-Ray System | Unexpected failure of electrical components within the CPI generator. | Class II | Open, Classified | |
| Z-1206-2023 | DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. CATALOG #(s): 8624181 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8624199 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F 8621617 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8622359 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F Note: PDU is a standalone Power Distribution Unit (PDU), plugged into the hospital outlet, which supplies Alternate Current (AC) to the Overhead Tube Crane (OTC). | After pressing and releasing the Z-Axis Motorized buttons on the Tube Head Display, the Overhead Tube Crane (OTC) could potentially continue the movement unexpectedly to a certain distance which could potentially result in a injury | Class II | Open, Classified | |
| Z-0806-2020 | Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and control x-rays for examination of various anatomical regions. The DR Operator Console is the user interface. All operator functions except positioning the Bucky assembly and controls for the collimator shutter are accomplished at the operator console. | Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm. | Class II | Terminated | |
| Z-1207-2019 | OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Console) The device is intended to be used for x-ray computed tomography and projection x-ray imaging of upper and lower extremities of adult patients and pediatric patients aged 12 and over. | When the user performs the re-assignment of a parent / companion pair, the parent volume is transferred to the new patient but the companion volume will remain in the original patient s exam. | Class II | Terminated | |
| Z-2651-2017 | DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China only) -- COMMON/USUAL NAME: DRX-Revolution --- The DRX-Revolution is a mobile system used to generate and control X-Rays for diagnostic procedures | Carestream found a single unit where four screws in the assembly were not applied in the manufacturing process. This could result in separation of the tube and yoke assembly. | Class II | Terminated | |
| Z-1138-2017 | Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) -- Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608 | The firm received a complaint alleging that a DRX Revolution System could not be stopped when applying the brake. The Revolution crashed into an elevator. | Class II | Terminated | |
| Z-1052-2017 | Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System Diagnostic ultrasound imaging or fluid flow analysis of the human body | Software error; Carestream Health Inc, received a complaint stating that when a user accidentally obtains a measurement value of 0 and corrects the value in the report, the resulting measurement unit is not displayed, i.e., centimeters or millimeters. As such, the user expects that the measurement is taken calculated in centimeters, consistent with other values in the report. In actuality, the measurement is taken in millimeters. When this updated measurement is used in an average calculation, the result appears incorrect as two measurements are interpreted as centimeters while the user corrected value is interpreted as millimeters. If the user selects a Calc Result display as Min or Max, the values are also interpreted as millimeters when centimeters were expected. | Class II | Terminated | |
| Z-2217-2016 | Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 1738822 --- Common Name: Touch Ultrasound Diagnostic ultrasound imaging or fluid flow analysis of the human body | A software issue related to the generic volume measurement functionality could result in the volume of the subject anatomy being overestimated. For example, measurement results of the anatomy may appear enlarged or distended when it actually is not. | Class II | Terminated | |
| Z-1594-2016 | CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1056191, DICOM STORE SCP/FOR IMAGE SUITE V4: REF/Catalog # 6566988; Image Suite V4 Bundles: IMAGESUITE STANDALONE PACS: REF/Catalog # 1741289, IMAGESUITE STANDALONE PACS FOR INDIA: REF/Catalog # 1741297; Carestream PRO (Image Suite V4): PRO Medical Wireless GOS System-Desktop: REF/Catalog # 1741891, PRO Wireless System Laptop: REF/Catalog # 1741925, PRO Wireless System - w/o Computer: REF/Catalog # 1741933, PRO Tethered System Desktop: REF/Catalog # 1741941, PRO Tethered System Laptop: REF/Catalog # 1741958, PRO Tether System - w/o Computer: REF/Catalog # 1741966, PRO Fixed System - w/o Computer: REF/Catalog # 1741974, PRO Medical Wireless CsI System-Desktop: REF/Catalog # 1741982, PRO Wireless System Laptop: REF/Catalog # 1742006, PRO Wireless System - w/o Computer: REF/Catalog # 1742014, PRO Tethered System Desktop: REF/Catalog # 1742022, PRO Tethered System Laptop: REF/Catalog # 1742055, PRO Tether System - w/o Computer: Catalog # 1742063; PRO Fixed System - w/o Computer: REF/Catalog # 1742089 -- Made in U.S.A. by: Carestream Health, Inc., 150 Verona Street, Rochester, NY 14608 --- CLASSIFICATION NAME: System, Image Processing, Radiological The Carestream Image Suite System is an image management system whose intended use is to receive, process, review, display, print and archive images and data from CR and DR modalities. This excludes mammography applications in the United States | Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospital stating that the annotation on the overlay is displayed as "L (Left)", when it should be "R(Right)". | Class II | Terminated | |
| Z-1593-2016 | CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-PACS/F IMG ST/POC&VITA: REF/Catalog # 1036508; MINI-PACS/F IMG ST/CLASSIC/INDIA: REF/Catalog # 1036417; MINI-PACS/F IMG ST/ POC&VITA /INDIA: REF/Catalog # 1036425 -- Made in USA by: Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608 --- CLASSIFICATION NAME: System, Image Processing, Radiological The Carestream Image Suite System is an image management system whose intended use is to receive, process, review, display, print and archive images and data from CR and DR modalities. This excludes mammography applications in the United States. | Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospital stating that the annotation on the overlay is displayed as "L (Left)", when it should be "R(Right)". | Class II | Terminated | |
| Z-2449-2015 | CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients. | Software defect that impacts image alignment when using the automatic stitching option for long length images. The defect could cause stitching inconsistencies which may go undetected on a radiograph. | Class II | Terminated | |
| Z-1378-2015 | CS 8100 3D, CATALOG # (s): 5311162, 5311188. Intended to produce complete or segmented tomographic digital panoramic X-ray images and three-dimensional digital X-ray images of the dentomaxillo-facial area to be used at the direction of healthcare professionals as diagnostic support for pediatric and adult patient. | Units device head descended unexpectedly | Class II | Terminated | |
| Z-1377-2015 | CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 Intended to produce complete or segmented tomographic digital panoramic X-ray images to be used at the direction of healthcare professionals of the dento-maxillo-facial region of the human anatomy as diagnostic support for pediatric and adult patient. | Units device head descended unexpectedly | Class II | Terminated | |
| Z-0800-2015 | DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all other countries) --- Carestream Health, Inc. The DRX-Revolution Mobile X-Ray System is a mobile imaging system that incorporates a self contained x-ray generator, image receptor, imaging display and software for acquiring medical diagnostic images outside of a standard x-ray room. The DRX-Revolution Mobile X-Ray System has a motor for driving the system so that the operator does not have to push the system, but can walk behind the system while it is moving from one location to another. | While servicing a unit at a customer site, a field engineer discovered a broken bolt from the carriage assembly. Carestream has identified an issue related to the DRX-Revolution Mobile X-Ray System in which bolts that secure the x-ray tube assembly/boom to the device mounting block may break. It has been determined that this issue is a result of an improperly assembled part which holds the x-ray | Class II | Terminated | |
| Z-0820-2015 | CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer. | Reduced mammographic image quality when attempting to print true size multi-format images | Class II | Terminated | |
| Z-2177-2014 | Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7500 system is a permanently installed diagnostic x-ray system composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DR 7500 System is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. | An on-site evaluation of the equipment parts that attach the Beta Assembly (x-ray tube and collimator) to the Over Head Tube Crane (OTC) Telescope was completed by Carestream Health (CSH) Service Engineering. Inspection of these parts revealed that the tab on the lock washer was not bent into the lock nut recess and because the Beta Assembly detached from the OTC telescope, the lock nut was not sufficiently tightened. | Class II | Terminated | |
| Z-2143-2014 | Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc. | The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the dental intraoral film. This may cause confusion for the dental practitioner. If the processed film is placed on the view box by referencing the film's raised dot, the image orientation will be rotated 180 degrees. | Class III | Terminated | |
| Z-2142-2014 | INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc. | The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the dental intraoral film. This may cause confusion for the dental practitioner. If the processed film is placed on the view box by referencing the film's raised dot, the image orientation will be rotated 180 degrees. | Class III | Terminated | |
| Z-2137-2014 | KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A permanently installed diagnostic x-ray system composed of 3 main components: an operator console, U-Arm assembly with x-ray tube including a collimator, and a stationary generator. | A control system failure may cause the U-Arm to move downward unexpectedly when the Radiology Technologist is positioning the equipment using the "Up" or "Down" control buttons. Downward movement occurs at three times the normal rate of speed and will continue until the device control button is released, the Emergency Stop button is activated or the equipment Bump Sensor contacts an object. | Class II | Terminated | |
| Z-1128-2014 | Model Kodak 2200 Intraoral X-Ray System, Catalog Numbers 5303177, 5303169, 5303151, XR-5154323 -- Carestream Health, Inc. Made in France -- --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraoral with timer --- There are four major components: x-ray tube, x-ray generator, collimator and image receptor. These systems are permanently installed diagnostic dental x-ray systems for generation of x-rays for examination of the teeth, jaw and oral structures. | Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage. | Class II | Terminated | |
| Z-1127-2014 | Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 -- Made in France -- TROPHY 77435 Marne La Vallee --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraoral with timer --- There are four major components: x-ray tube, x-ray generator, collimator and image receptor. These systems are permanently installed diagnostic dental x-ray systems for generation of x-rays for examination of the teeth, jaw and oral structures. | Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage. | Class II | Terminated | |
| Z-0844-2014 | KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in U.S.A. | Carestream Health, Inc. has recalled DR 7500 Dual Detector System utilizing Version 5.X Software due to a possible patient image display error. | Class II | Terminated | |
| Z-0798-2014 | DR 7500 with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. | Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement. | Class II | Terminated | |
| Z-0797-2014 | DRX-Evolution with CSH WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. | Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement. | Class II | Terminated |
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