Recall Z-1699-2017 ยท FSY Light, Surgical, Ceiling Mounted
Stryker Communications
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), 0682001
| Date | Mar 10, 2017 (initiated Feb 28, 2017) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | Stryker sent an Urgent Medical Device Correction letter dated March 3, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. Distributors will notify customers via tracked Customer Notification Letter. A method of written communication will include a confirmation of delivery. For questions contact Stryker Technical Support at 800-243-5135 or comm.techservices@stryker.com |
| Quantity | 292 devices (in US) |
| Distribution | Worldwide distribution - United States Nationwide - Australia, Canada, Great Britain, Japan, Netherlands and Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060802 | VISUM LED SURGICAL LIGHTING SYSTEM Stryker Communications Corp., Apr 7, 2006 |