Chromophare Surgical Light System , REF CH00000001 recallZ-1506-2024 · Stryker Communications · initiated Feb 8, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Communications or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to insufficient mounting force the stability of surgical light system cannot be guaranteed.
FDA root cause category: Employee error
What the company is doing
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 [email protected]. 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.
Recall details
- Recall number
- Z-1506-2024
- Status
- Open, Classified
- Initiated by the company
- Feb 8, 2024
- Posted by the FDA
- Apr 9, 2024
- Recalling firm
- Stryker Communications
- Quantity
- 1 unit
- Product code
- FSY
- FDA submissions
- K120392
- Distribution
- US: None OUS: Chili
Product description
Chromophare Surgical Light System , REF CH00000001
Code information (models, lots, serial numbers)
S/N:03857056/ UDI: 07613327296167
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Chromophare CH00000001Berchtold Holding GmbH · DEVICE, MEDICAL EXAMINATION, AC POWERED3 recalls50 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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