FDA Medical Device Recalls (openFDA)
Stryker Communications: Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System.
- Recall number
- Z-0692-2018
- Recalling firm
- Stryker Communications
- Product
- Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System.
- Status
- Terminated
- Initiated
- 2018-01-26
- Posted
- not on file
- Terminated
- 2019-03-19
- Reason
- The mounts on the monitor may have an insufficient (missing or incomplete) weld.
- Root cause
- Process control
- Action
- The recalling firm issued letters dated 1/26/2018 via FedEx on 1/26/2018 explaining the issue and the potential adverse consequences.
- Quantity
- 850
- Distribution
- Distribution was made to medical facilities nationwide, including government and military distribution. Foreign distribution was made to Canada, Belgium, China, United Kingdom, UAE, France, Germany, Spain, Japan, Ecuador, and Russia.
- Lot, serial or model codes
- United States and Canada: Serial numbers DFP-075-0307-0001 to DFP-075-1014-0230; International: Serial numbers 6145060-O11628 to 6176090-V14102
- 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