FDA Medical Device Recalls (openFDA)
Stryker Communications: Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medical lights used for local illumination of the patients' body so that illnesses, injuries and disabilities can be diagnosed and treated
- Recall number
- Z-2248-2017
- Recalling firm
- Stryker Communications
- Product
- Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medical lights used for local illumination of the patients' body so that illnesses, injuries and disabilities can be diagnosed and treated
- Status
- Terminated
- Initiated
- 2017-04-21
- Posted
- not on file
- Terminated
- 2017-09-20
- Reason
- The exam light may have a tolerance issue with the adapter assembly, which could potentially not allow the snap ring to be seated correctly. If this is the case, there could be insufficient mount force that may cause the equipment to fall, resulting in serious injury.
- Root cause
- Component design/selection
- Action
- Stryker Communications sent an Urgent Medical Device Recall letter to all affected customers. A Stryker Representative will contact their facility to schedule a service visit. to replace the adapter assembly to resolve the tolerance issue affected units. Customers with questions were instructed to Stryker Technical Support at 800-243-5135 or comm.techservice@stryker.com. For questions regarding this recall call 972-834-8656.
- Quantity
- 57 units
- Distribution
- Worldwide Distribution - US and Canada
- Lot, serial or model codes
- Serial Numbers: 7735170-X68377, 7735170-X68397, 7735170-X14846, 7735170-X15688, 7735170-X14492, 7735170-X14495, 7735170-X14497, 7735170-X14501, 7735170-X14502, 7735170-X14504, 7735170-X14506, 7735170-X14507, 7735170-X14508, 7735170-X14510, 7735170-X68383, 7735170-X68384, 7735170-X68385, 7735170-X68386, 7735170-X68393, 7735170-X68394, 7735170-X68395, 7735170-X68396, 7735170-X68392, 7735170-X68400, 7735170-X68401, 7735170-X15607, 7735170-X15608, 7735170-X15609, 7735170-X15610, 7735170-X15611, 7735170-X15612, 7735170-X15613, 7735170-X15614, 7735170-X15615
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KZF
- 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