Acteon, Inc.
Mount Laurel, NJ, US
ACTEON, INC. appears in FDA device records in Mount Laurel, NJ. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 8 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 Acteon, Inc. 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.
- Villa Radiology Systems LLCenforcement report, recall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2243757 | 2243757 | ACTEON, INC. | 1001 Briggs Rd Ste 220, Mount Laurel, NJ 08054 US | 2026 | and 14 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HRXArthroscope
- EOQBronchoscope (Flexible Or Rigid)
- MVLCord, Retraction
- FFFCover, Biopsy Forceps
- FAJCystoscope And Accessories, Flexible/Rigid
- FFLDislodger, Stone, Basket, Ureteral, Metal
- DZIDrill, Bone, Powered
- FASElectrode, Electrosurgical, Active, Urological
- OCZEndoscopic Grasping/Cutting Instrument, Non-Powered
- OCXEndoscopic Irrigation/Suction System
- HTDForceps
- EKXHandpiece, Direct Drive, Ac-Powered
- HIHHysteroscope (And Accessories)
- JDXInstrument, Surgical, Sonic And Accessory/Attachment
- CCWLaryngoscope, Rigid
- EOBNasopharyngoscope (Flexible Or Rigid)
- ERAOtoscope
- FJLResectoscope
- FDCResectoscope, Working Element
- FDGRetractor, Fiberoptic
- ELCScaler, Ultrasonic
- FGKTripsor, Stone, Bladder
- ECBUnit, Syringe, Air And/Or Water
- EZOUrethrotome
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1066-2017 | Apollo EZ: Model: 9784152036 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures. | The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) The directions for use (device labeling and instructions for use) did not contain an explicit exclusion of the prohibited area. 3.) The movement was activated inadvertently and continuously. and it was not released (the movement requires continuous activation). 4.) Delayed activation of the emergency stop. | Class II | Open, Classified | |
| Z-1065-2017 | Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures. | The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) The directions for use (device labeling and instructions for use) did not contain an explicit exclusion of the prohibited area. 3.) The movement was activated inadvertently and continuously. and it was not released (the movement requires continuous activation). 4.) Delayed activation of the emergency stop. | Class II | Open, Classified | |
| Z-1064-2017 | Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131, 9784120231, 9784130131 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures. | The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) The directions for use (device labeling and instructions for use) did not contain an explicit exclusion of the prohibited area. 3.) The movement was activated inadvertently and continuously. and it was not released (the movement requires continuous activation). 4.) Delayed activation of the emergency stop. | Class II | Open, Classified | |
| Z-1063-2017 | Juno DRF; Model: 709020 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures. | The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) The directions for use (device labeling and instructions for use) did not contain an explicit exclusion of the prohibited area. 3.) The movement was activated inadvertently and continuously. and it was not released (the movement requires continuous activation). 4.) Delayed activation of the emergency stop. | Class II | Open, Classified | |
| Z-0129-2016 | Owandy Radiology I -MAX Touch 3D X-ray | It has been discovered that due to lack of information accompanying documents the product fails to comply with 21CfR 1020.33(c),1020.33(d),1020.33(g),and 1020.330). | Class II | Terminated | |
| Z-0128-2016 | Villa Sistemi Rotograph EVO 3D X-ray | It has been discovered that due to lack of information accompanying documents the product fails to comply with 21CfR 1020.33(c),1020.33(d),1020.33(g),and 1020.330). | Class II | Terminated | |
| Z-1079-2015 | Juno DFR X-ray system | The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality | Class II | Terminated | |
| Z-2160-2013 | Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures | It has been discovered that the Air Kerma rate information is inconsistent in Continuous Fluoro modes 30x30 (12"x12") and 15x15 (6"x6). This could result in a deviation of the displayed values of Air Kerma Rate and Cumulated Air Kerma from the actual values greater then +/-35% and then in a failure to comply with the requirements of 21 CFR 1020.32(k)(6 | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain