Visum LED Surgical Lights, Ceiling Mounted Surgical Light. The Visum LED surgical light is intended to illuminate the op
FDA device recall Z-0913-2012 · posted 2012-01-26 · Terminated
Recall details
- Recalling firm
- Stryker Communications Corp
- Reason for recall
- 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.
- Action taken
- The firm sent "Urgent: Medical Device Correction" letters dated 11/07/2011 to their domestic and international customers. The letter informed customers of the remote risk of the light detaching from the arm and recommended continued use of the product. A representative will contact them about scheduling an appointment to inspect the lights. Contact Technical Services at 1-866-841-5663 for questions.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FSY
- Quantity affected
- 1143 Devices
- Distribution
- Worldwide Distribution - USA, and the countries of Australia, Canada, Hong Kong, Brazil, Sweden, India, Japan, Korea, Ecuador, Venezuela, Mexico, Denmark, Great Britain, and New Zealand.
- Date initiated
- 2011-11-07
- Date posted
- 2012-01-26
- Date terminated
- 2012-08-17
- Location
- Flower Mound, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VISUM LED SURGICAL LIGHTING SYSTEM (K060802) | Stryker Communications Corp. | 2006-04-07 |
| STRYKER VISUM SURGICAL LIGHTING SYSTEM (K031068) | Stryker Endoscopy | 2003-08-12 |