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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker VISUM LED Surgical Lights

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  Class 2 Device Recall Stryker VISUM LED Surgical Lights see related information
Date Initiated by Firm April 15, 2010
Date Posted May 21, 2010
Recall Status1 Terminated 3 on January 24, 2011
Recall Number Z-1640-2010
Recall Event ID 55477
510(K)Number K0608022  K031068  K033132  
Product Classification Ceiling Mounted Surgical Light - Product Code FSY
Product Stryker VISUM LED Surgical Lights (Ceiling Mounted Surgical Light), Catalog numbers: 0682001250, 0682001251.

Intended to illuminate the operative site during surgical procedures with high intensity light.
Code Information Product Numbers: Product Installed Between January 2, 2008 and August 31, 2009 Lot Code: Product Installed Between January 1, 2008 and August 31, 2009
Recalling Firm/
Manufacturer		 Stryker Communications Corp
1410 Lakeside Pkwy Ste 100
Flower Mound TX 75028-4026
For Additional Information Contact
972-410-7310
Manufacturer Reason
for Recall		 Installation records are incomplete.
FDA Determined
Cause 2		 Employee error
Action An Urgent: Medical Device Product Correction customer notification letter, dated 4/15/2010, has been sent out to all affected accounts via regular mail in the form of a certified, return request receipt letter. Accounts will receive a follow-up phone call from a Stryker Representative to schedule a re-inspection of equipment to see if it mets established critical specifications or not. The firm recommends that customers continue using all Stryker Communications products listed in the notice. Questions can be directed to Katie Blackwell at 972-410-7660 or via email at StrykerCommunicationsRA@stryker.com.
Quantity in Commerce 608 (all lights and booms)
Distribution Nationwide Distribution
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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