The Stryker Visum¿ LED Surgical Lighting system is intended to illuminate the operative site duri...
FDA Device Recall #Z-1699-2017 — Class II — February 28, 2017
Recall Summary
| Recall Number | Z-1699-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 28, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker Communications |
| Location | Flower Mound, TX |
| Product Type | Devices |
| Quantity | 292 devices (in US) |
Product Description
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
Reason for Recall
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.
Distribution Pattern
Worldwide distribution - United States Nationwide - Australia, Canada, Great Britain, Japan, Netherlands and Puerto Rico
Lot / Code Information
"Serial Numbers: 100000000098399 100000000099187 100000000099193 100000000093937 100000000094391 100000000093936 100000000087555 100000000091032 100000000093938 100000000093928 100000000093939 100000000098397 100000000092672 100000000093927 100000000106675 100000000106685 100000000109560 100000000109569 100000000109570 100000000086360 100000000089194 100000000091766 100000000091778 100000000098401 100000000099325 100000000103228 100000000090520 100000000102434 100000000102439 100000000103111 100000000088303 100000000089467 100000000094993 100000000095927 100000000101580 100000000092699 100000000101590 100000000101591 100000000103686 100000000109291 100000000097048 100000000112633 100000000087549 100000000094982 100000000091762 100000000112607 100000000112609 100000000091531 100000000106681 100000000106682 100000000106684 100000000106159 100000000091728 100000000103271 100000000090522 100000000099356 100000000089970 100000000090530
Other Recalls from Stryker Communications
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2620-2025 | Class II | Chromophare Surgical Light System, REF: CH00000... | Jul 15, 2025 |
| Z-1506-2024 | Class II | Chromophare Surgical Light System , REF CH00000001 | Feb 8, 2024 |
| Z-1297-2021 | Class II | S-Series Equipment Management System; Model Num... | Jan 29, 2021 |
| Z-1602-2020 | Class II | Berchtold Chromophare Ceiling Mounted Surgical ... | Oct 11, 2019 |
| Z-2446-2019 | Class II | Berchtold Chromophare Dual Monitor Carrier Arm ... | Aug 1, 2019 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.