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U.S. Department of Health and Human Services

Class 2 Device Recall Chromophare Surgical Light System

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  Class 2 Device Recall Chromophare Surgical Light System see related information
Date Initiated by Firm February 08, 2024
Date Posted April 09, 2024
Recall Status1 Open3, Classified
Recall Number Z-1506-2024
Recall Event ID 94199
510(K)Number K120392  
Product Classification Light, surgical, ceiling mounted - Product Code FSY
Product Chromophare Surgical Light System , REF CH00000001
Code Information S/N:03857056/ UDI: 07613327296167
Recalling Firm/
Manufacturer		 Stryker Communications
571 Silveron Blvd
Flower Mound TX 75028
For Additional Information Contact Ashley Lower
972-410-7100
Manufacturer Reason
for Recall		 Due to insufficient mounting force the stability of surgical light system cannot be guaranteed.
FDA Determined
Cause 2		 Employee error
Action On February 19, 2024, Stryker issued a Urgent Medical Device Recall notification via XXX. In addition to notifying consignees about the recall. Stryker asked consignees to take the following actions: Inform individuals within your organization who need to be aware of this action. 2. Check your internal inventory to locate the product listed in the product affected grid. If affected product is found, segregate and do not use the product. 3. Complete and sign the enclosed Business Reply Form on Attachment A and return to CommunicationsRA1@stryker.com. 4. A Sales Representative or Field Service Technician will be in contact with your facility to schedule a service visit to perform the recall activities. 5. Maintain awareness of this communication internally until all required actions have been completed within your facility. Response is required.
Quantity in Commerce 1 unit
Distribution US: None OUS: Chili
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 = BERCHTOLD GMBH & CO. KG
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