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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Visum LED Surgical Light

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  Class 2 Device Recall Stryker Visum LED Surgical Light see related information
Date Initiated by Firm November 13, 2018
Create Date May 21, 2019
Recall Status1 Open3, Classified
Recall Number Z-1388-2019
Recall Event ID 82476
510(K)Number K060802  
Product Classification Light, surgical, ceiling mounted - Product Code FSY
Product EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, with the following catalog numbers: 0682001286, EDS Light Suspension, Central Axis, 5P/FP; 0682001298, EDS Light Suspension, Central Axis, 5P; 0682001299, EDS Light Suspension, Central Axis, 5P/5P; 0682001300, EDS Light Suspension, Central Axis, FP/5P/5P; 0682001432, EDS Light Suspension, Central Axis 9P/FP; 0682001433, EDS Light Suspension, Central Axis, 9P; 0682001434, EDS Light Suspension, Central Axis, 9P/5P; and 0682001435, EDS Light Suspension, Central Axis, FP/9P/5P.

Product Usage:
The lighting system is intended to illuminate the operative site during surgical procedures with high intensity light.
Code Information Serial numbers 100000000065406 to 100000000106685.
Recalling Firm/
Manufacturer		 Stryker Communications
571 Silveron Blvd
Flower Mound TX 75028
For Additional Information Contact Ms. Julie Baker
972-834-8656
Manufacturer Reason
for Recall		 There is a potential the joint in the suspension of the device is insufficiently assembled.
FDA Determined
Cause 2		 Employee error
Action The recalling firm issued letters dated 11/13/2018 via FedEx informing to customers. The letter identified the affected product problem and actions to be taken. The customer is asked to disseminate the information within their organization. A response form was enclosed to indicate the customer has read and understands the instructions in the letter. The form was to be returned to the recalling firm via email. Customer was notified that a Stryker representative will begin visiting customer facilities in November to inspect their equipment. For questions contact " Stryker Technical Support at (800) 243-5135 or comm.techservices@stryker.com
Quantity in Commerce 3,176 devices
Distribution Distribution was nationwide, including Puerto Rico. There was also government/military distribution. Foreign distribution was made to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Ecuador, France, India, Japan, Korea, Mexico, Netherlands, Spain and United Kingdom.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FSY and Original Applicant = STRYKER COMMUNICATIONS CORP.
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