STRYKER Communications, Inc.
Flower Mound, TX, US
STRYKER Communications, Inc. appears in FDA device records in Flower Mound, TX. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 47 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for STRYKER Communications, Inc. between 2004 and 2013. The busiest year on record is 2004, with 1. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 1 |
| 2006 | 1 |
| 2010 | 1 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K132747 | VISUM BLADE LED SURGICAL LIGHTING SYSTEM | FSY | Substantially Equivalent | |
| K100852 | STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000 | OCS | Substantially Equivalent | |
| K060802 | VISUM LED SURGICAL LIGHTING SYSTEM | FSY | Substantially Equivalent | |
| K033132 | STRYKER SWITCHPOINT INFINITY | GCJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2031963 | 3002975342 | STRYKER Communications, Inc. | 571 Silveron Blvd., Flower Mound, TX 75028 US | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HRXArthroscope
- KQMCamera, Surgical And Accessories
- HXDClamp
- KZFDevice, Medical Examination, Ac Powered
- KKXDrape, Surgical, Antimicrobial
- OCSEndoscopic Video Imaging System/Component, Gastroenterology-Urology
- HIGInsufflator, Hysteroscopic
- GCJLaparoscope, General & Plastic Surgery
- FSYLight, Surgical, Ceiling Mounted
- EYDStirrups
- CCXSupport, Patient Position
- LWGSurgical Table Cushion
- BWNTable And Attachments, Operating-Room
- FQOTable, Operating-Room, Ac-Powered
- GDCTable, Operating-Room, Electrical
- LGZWarmer, Thermal, Infusion Fluid
Recall records
Showing 25 of 47| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1688-2026 | Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001 | Surgical light assembly may not adequate support the weight of the ceiling cover. | Class II | Open, Classified | |
| Z-2620-2025 | Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034 | Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur. | Class II | Open, Classified | |
| Z-1506-2024 | Chromophare Surgical Light System , REF CH00000001 | Due to insufficient mounting force the stability of surgical light system cannot be guaranteed. | Class II | Open, Classified | |
| Z-1297-2021 | S-Series Equipment Management System; Model Number(s):0682400550; UDI: 07613327400502 Components that are affected within the S-Series Finished Good Model Number o P38198 - ASM, MFR CONTROLLER, FIXED STANDARD o P38199 - ASM, MFR CONTROLLER, LIFT STANDARD o P40553 - ASM, MFR HANDLE REPAIR, LIFTING, S-SERIES, STANDARD o P40554 - ASM, MFR HANDLE REPAIR, FIXED, S-SERIES, STANDARD o P46269 - ASSY, MFR CONTROLLER UPGRADE, STANDARD | The manufacturer has become aware that there is a likelihood that the S-Series Equipment Management System Capacitive Touch Controls on the MFRs rotational electrical magnetic brakes may disengage when an electrocautery device is in use. | Class II | Open, Classified | |
| Z-1602-2020 | Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000 | The firm has become aware that there is a likelihood that a missing snap ring or spanner nut may result in an insufficient mount force that causes the surgical light to fall. If the suspension of the surgical light falls, it may potentially cause serious injuries to Health Care Providers and/or patients. | Class II | Terminated | |
| Z-2446-2019 | Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System. | The mounts on the monitor may have an insufficient weld. | Class II | Terminated | |
| Z-2540-2019 | Berchtold Chromophare F628 Surgical Lights. Product Usage: The medical lights are for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, injury, and disability. The surgical lights may only be used in rooms used for medical purposes that have been equipped in accordance with VDE 0100-710 or IEC 60364-7-10 in accordance with the regulations. | The back cover of the light head was insufficiently assembled and could potentially fall off the light. | Class II | Open, Classified | |
| Z-2539-2019 | Berchtold Chromophare F528 Surgical Lights. Product Usage: The medical lights are for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, injury, and disability. The surgical lights may only be used in rooms used for medical purposes that have been equipped in accordance with VDE 0100-710 or IEC 60364-7-10 in accordance with the regulations. | The back cover of the light head was insufficiently assembled and could potentially fall off the light. | Class II | Open, Classified | |
| Z-1388-2019 | EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, with the following catalog numbers: 0682001286, EDS Light Suspension, Central Axis, 5P/FP; 0682001298, EDS Light Suspension, Central Axis, 5P; 0682001299, EDS Light Suspension, Central Axis, 5P/5P; 0682001300, EDS Light Suspension, Central Axis, FP/5P/5P; 0682001432, EDS Light Suspension, Central Axis 9P/FP; 0682001433, EDS Light Suspension, Central Axis, 9P; 0682001434, EDS Light Suspension, Central Axis, 9P/5P; and 0682001435, EDS Light Suspension, Central Axis, FP/9P/5P. Product Usage: The lighting system is intended to illuminate the operative site during surgical procedures with high intensity light. | There is a potential the joint in the suspension of the device is insufficiently assembled. | Class II | Open, Classified | |
| Z-0828-2018 | Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000. Product Usage: Chromophare surgical lights are medical lights for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, injury, and disability. The surgical lights may only be used in rooms used for medical purposes that have been equipped in accordance with VDE 0100-710 or IEC 60364-7-10 in accordance with the regulations. The Chromophare surgical lights consist of a ceiling tube, SK Box swivel arm support, and a light head. The light head is mounted on a cardanic suspension unit and can be turned, swiveled and tilted in any direction. The spatial repositioning of the light head makes use of the 360 degree rotating swivel/horizontal arm. The 360 degree rotating spring arm is used to adjust the height. The light can be mounted in several configurations, such as a single/dual ceiling mount, a boom-integrated suspension mount, a wall mount, or a mobile roll stand. | The device could have a missing spanner nut and snap ring which could potentially result in the equipment falling. | Class II | Terminated | |
| Z-0692-2018 | Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System. | The mounts on the monitor may have an insufficient (missing or incomplete) weld. | Class II | Terminated | |
| Z-2248-2017 | Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medical lights used for local illumination of the patients' body so that illnesses, injuries and disabilities can be diagnosed and treated | The exam light may have a tolerance issue with the adapter assembly, which could potentially not allow the snap ring to be seated correctly. If this is the case, there could be insufficient mount force that may cause the equipment to fall, resulting in serious injury. | Class II | Terminated | |
| Z-1699-2017 | The Stryker Visum LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light. Affected part numbers are 0682001432 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/FP), 0682001286 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P/FP), 0682001298 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P), 0682001299 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P/5P), 0682001300 (EDS LIGHT SUSPENSION, CENTRAL AXIS, FP/5P/5P), 0682001433 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P), 0682001434 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/5P), 0682001435 (EDS LIGHT SUSPENSION, CENTRAL AXIS, FP/9P/5P) Product Usage: The Stryker Visum LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light | The potential hazard that can arise for the combination of the missing screws and the overloading by the end user is insufficient mount force that causes the equipment to fall. | Class II | Terminated | |
| Z-2056-2014 | BAM (SHAPE) ARM, RIGHT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682000977, and the Arm part number in the kit is 01000221456. The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS. | During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present. | Class II | Terminated | |
| Z-2055-2014 | BAM (SHAPE) ARM, LEFT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as component of kit part number 0682000976, and the Arm part number in the kit is P17087. The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS. | During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present. | Class II | Terminated | |
| Z-2054-2014 | SHAPE ARM, SINGLE WITH GCX MOUNT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as component of kit part number 0682400256 and the Arm part number in the kit is P17087 . The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS. | During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present. | Class II | Terminated | |
| Z-2053-2014 | SHAPE ARM, DUAL SH2, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682400254 and the Arm part number in the kit is P17084 . The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS. | During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present. | Class II | Terminated | |
| Z-2052-2014 | SHAPE ARM, SINGLE, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682400253 and the Arm part number in the kit is P17085. . The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS. | During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present. | Class II | Terminated | |
| Z-1992-2013 | Stryker Visum 300 Ceiling-mounted Exam Light. | Potential incomplete final weld on the drop tube flange. | Class II | Terminated | |
| Z-0657-2013 | (l) Visum Halogen Surgical Light, (2) Visum LED Surgical Light, (3) Stryker Flat Panel and Navigation Arm The Spring Arm Circlip is part of the Stryker Spring Arm used in multiple configurations as a component of the (1)Visum Halogen Surgical Light, (2)Visum LED Surgical Light, and (3)Stryker Flat Panel and Navigation Arm. The Spring Arm that is subject to this field action suspends loads, is a conduit for power/data, and facilitates multi-directional movement. The Spring Arms that have been identified within scope are replacement parts that have potentially been serviced incorrectly. | Stryker has become aware that there is a low likelihood of incomplete engagement of the Spring Arm Circlip during service or replacement of the Spring Arm. If the Spring Arm Circlip is not fully seated, the Spring Arm could separate and fall along with the surgical lights or monitors mounted to the end of the Spring Arm. To date, there have been no serious injuries reported from the incomplete e | Class II | Terminated | |
| Z-0913-2012 | Visum LED Surgical Lights, Ceiling Mounted Surgical Light. The Visum LED surgical light is intended to illuminate the operative site during surgical procedures with high intensity light. | Stryker has identified a potential structural issue with the Visum LED surgical light(s). During a complaint investigation, Stryker became aware that there was a possibility that incorrect assembly could result in the light head beginning to separate from the suspension arm. In the event the light separates and falls from the arm, it could lead to serious injury. | Terminated | ||
| Z-0138-2012 | Stryker Communications, 1410 Lakeside Parkway, # 100, Flower Mound, TX 75208 Stryker EDS (Equipment Delivery System) Booms and Flat Panel Suspensions are intended for use as ceiling-mounted devices to support or position equipment, monitors, cameras or light heads and/or deliver gases and/or electricity to these equipments. They are available in articulating and non-articulating configurations, in single or tandem (pair) configuration, with different shelves configuration to allow various load capacities. | Installation records for the SwitchPoint Infinity, Booms, Lights, and Flat Panel systems are incomplete or inadequate. | Terminated | ||
| Z-0137-2012 | Visum LED Surgical Lights/ Visum Halogen Surgical Lights. Stryker Communications, 1410 Lakeside Parkway, # 100, Flower Mound, TX 75208 Visum LED Surgical Lights and Visum Halogen Surgical Lights are ceiling mounted devices which provide illumination via LED lights and halogen bulbs. All systems are ceiling or wall mounted lights and each provides sufficient illumination with high intensity light for all types of surgical procedures. | Installation records for the SwitchPoint Infinity, Booms, Lights, and Flat Panel systems are incomplete or inadequate. | Terminated | ||
| Z-0136-2012 | SwitchPoint Infinity Control System Stryker Communications, 1410 Lakeside Parkway, # 100, Flower Mound, TX 75208 The SwitchPoint Infinity (SPI) Control System is an integrated voice, video, data router and teleconferencing interface for operating rooms. The SwitchPoint Infinity is used for direct control of room equipment, audio/video equipment, and indirect control of surgical equipment in the operating room. | Installation records for the SwitchPoint Infinity, Booms, Lights, and Flat Panel systems are incomplete or inadequate. | Terminated | ||
| Z-1611-2011 | MMP 200 Articulating Booms, Catalog Number 0682-000-604SX, Product Number 0682-001-060C. Used for operating room equipment. | Utilization of incorrect screws resulted in inadequate thread engagement reducing the load bearing capability of the product. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain