FDA Medical Device Recalls (openFDA)
Stryker Communications: Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000
- Recall number
- Z-1602-2020
- Recalling firm
- Stryker Communications
- Product
- Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000
- Status
- Terminated
- Initiated
- 2019-10-11
- Posted
- not on file
- Terminated
- 2022-10-18
- Reason
- The firm has become aware that there is a likelihood that a missing snap ring or spanner nut may result in an insufficient mount force that causes the surgical light to fall. If the suspension of the surgical light falls, it may potentially cause serious injuries to Health Care Providers and/or patients.
- Root cause
- Other
- Action
- On October 11, 2019, a "Urgent Medical Device Correction" letter was sent to all affected customers via FedEx. In addition to explaining the recall, the recall letter as customers to take the following action: Please assure this notification letter is disseminated within your organization. A Stryker Representative will begin scheduling visits to customer facilities to perform inspections. This correction is expected to last one year. During the inspection, the Stryker Representative will perform a visual inspection on the lower portion of the Chromophare Ceiling Mounted Surgical Light Suspension. If a nonconforming unit is found, Stryker will replace the non-conforming Chromophare Ceiling Mounted Surgical Light Suspension with a new Chromophare Ceiling Mounted Surgical Light Suspension. In the meantime, the lights can continue to remain in full use. If you have any questions or notice any issues regarding this correction: " Stryker Technical Support at 866-841-5663 or comm.techservices@stryker.com " Nicole Kubat, Senior RA Compliance Specialist at 469-470-4318 or Nicole.Kubat@stryker.com " E-mail: CommunicationsRA1@stryker.com
- Quantity
- 1415 Surgical Lights
- Distribution
- US: Nationwide OUS: Canada
- Lot, serial or model codes
- Serial Number Range: 091316 70016 through 083117-73252
- 510(k) numbers
- not on file
- 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