FDA Medical Device Recalls (openFDA)
Stryker Endoscopy: Stryker Digital Capture System Ultra (SDC Ultra), Model Number 240-050-988, Stryker Endoscopy, image and video archiving system.
- Recall number
- Z-1316-2008
- Recalling firm
- Stryker Endoscopy
- Product
- Stryker Digital Capture System Ultra (SDC Ultra), Model Number 240-050-988, Stryker Endoscopy, image and video archiving system.
- Status
- Terminated
- Initiated
- 2008-02-15
- Posted
- 2008-09-11
- Terminated
- 2011-02-15
- Reason
- Patient Identification numbers and names may be applied to images from another patient due to a software issue. This failure mode can only occur when the pre-load function of the SDC ultra is used.
- Root cause
- Software design
- Action
- Stryker Endoscopy mailed Urgent Device Correction notices, dated February 14, 2008, to all consignees, and sales representatives will be supplied with a fix to distribute to the user base.
- Quantity
- 814 units distributed
- Distribution
- Worldwide distribution: USA, Canada, Greece, and Germany.
- Lot, serial or model codes
- Serial numbers 07H041654 - 08A069464, PP1.04
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LMB
- Firm FEI
- 2936485
- Firm city
- San Jose
- Firm state
- CA
- 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