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-2446-2019
- 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
- 2019-08-01
- Posted
- 2019-08-30
- Terminated
- 2021-04-27
- Reason
- The mounts on the monitor may have an insufficient weld.
- Root cause
- Process control
- Action
- The recalling letter issued letters on 8/1/2019 via Fed Ex.
- Quantity
- 52 devices
- Distribution
- Distribution was made to CA, CO, CT, FL, GA, IL, IN, MD, MI, MN, MO, NC, NH, NJ, NY, OH, PA, SC, TN, TX, and WI. There was foreign distribution to Canada and Germany. There was no government/military distribution.
- Lot, serial or model codes
- Serial numbers DFP-075-0307-0001 to DFP-075-1014-0230.
- 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