The Stryker Visum LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures w
FDA device recall Z-1699-2017 · posted 2017-03-10 · Terminated
Recall details
- Recalling firm
- Stryker Communications
- 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.
- Action taken
- 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
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FSY
- Quantity affected
- 292 devices (in US)
- Distribution
- Worldwide distribution - United States Nationwide - Australia, Canada, Great Britain, Japan, Netherlands and Puerto Rico
- Date initiated
- 2017-02-28
- Date posted
- 2017-03-10
- Date terminated
- 2018-01-08
- Location
- Flower Mound, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VISUM LED SURGICAL LIGHTING SYSTEM (K060802) | Stryker Communications Corp. | 2006-04-07 |