FDA Medical Device Recalls (openFDA)
Stryker Communications Corp: 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.
- Recall number
- Z-0913-2012
- Recalling firm
- Stryker Communications Corp
- Product
- 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.
- Status
- Terminated
- Initiated
- 2011-11-07
- Posted
- 2012-01-26
- Terminated
- 2012-08-17
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 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.
- Lot, serial or model codes
- Catalog Number: 0682001250, 0682001251, 0682001252, and 0682001253. Product Numbers: P10235 (Visum LED Surgical Light, Camera Ready), P10234 (Visum LED Surgical Light), P12875 (Visum LED Surgical Light Camera Ready - Low Ceiling), P12874 (Visum LED Surgical Light - Low Ceiling). Expiration date: There is no expiration date with the scope of the action. Serial Numbers: Product manufactured between October 2010 to July 2011 and in use by customer.
- 510(k) numbers
- ["K031068","K060802"]
- PMA numbers
- not on file
- Product code
- FSY
- Firm FEI
- 3002975342
- Firm city
- Flower Mound
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28