FDA Medical Device Recalls (openFDA)
Stryker Communications: Chromophare Surgical Light System , REF CH00000001
- Recall number
- Z-1506-2024
- Recalling firm
- Stryker Communications
- Product
- Chromophare Surgical Light System , REF CH00000001
- Status
- Open, Classified
- Initiated
- 2024-02-08
- Posted
- 2024-04-09
- Terminated
- not on file
- Reason
- Due to insufficient mounting force the stability of surgical light system cannot be guaranteed.
- Root cause
- 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
- 1 unit
- Distribution
- US: None OUS: Chili
- Lot, serial or model codes
- S/N:03857056/ UDI: 07613327296167
- 510(k) numbers
- ["K120392"]
- PMA numbers
- not on file
- Product code
- FSY
- Firm FEI
- 3002975342
- Firm city
- Flower Mound
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28