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U.S. Department of Health and Human Services

Class 2 Device Recall Visum LED Surgical Lights

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  Class 2 Device Recall Visum LED Surgical Lights see related information
Date Initiated by Firm November 07, 2011
Date Posted January 26, 2012
Recall Status1 Terminated 3 on August 17, 2012
Recall Number Z-0913-2012
Recall Event ID 60812
510(K)Number K060802  K031068  
Product Classification Light, surgical, ceiling mounted - Product Code FSY
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.
Code Information 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.
Recalling Firm/
Manufacturer		 Stryker Communications Corp
1410 Lakeside Pkwy Ste 100
Flower Mound TX 75028-4026
For Additional Information Contact Kim Graul
972-410-7310
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FSY and Original Applicant = STRYKER COMMUNICATIONS CORP.
510(K)s with Product Code = FSY and Original Applicant = Stryker Endoscopy
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