Recall Z-1316-2008
Stryker Endoscopy · initiated February 15, 2008
Product
Stryker Digital Capture System Ultra (SDC Ultra), Model Number 240-050-988, Stryker Endoscopy, image and video archiving system.
Codes / lots: Serial numbers 07H041654 - 08A069464, PP1.04
Reason for recall
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.
FDA-determined cause: Software design
Action taken
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.
Details
- Recall number
- Z-1316-2008
- Initiated
- February 15, 2008
- Posted by FDA
- September 11, 2008
- Terminated
- February 15, 2011
- Product code
- LMB – Device, Digital Image Storage, Radiological
- Quantity
- 814 units distributed
- Distribution
- Worldwide distribution: USA, Canada, Greece, and Germany.
- Recalling firm
- Stryker Endoscopy, San Jose, CA