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.
FDA Recall Z-0913-2012 · Posted 2012-01-26
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Recalling FirmStryker Communications Corp
Recall StatusTerminated
Product CodeFSY
Date Initiated2011-11-07
Date Terminated2012-08-17
Product Quantity1143 Devices
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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