Stryker Digital Capture System Ultra (SDC Ultra), Model Number 240-050-988, Stryker Endoscopy, image and video archiving
FDA device recall Z-1316-2008 · posted 2008-09-11 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- 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.
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LMB
- Quantity affected
- 814 units distributed
- Distribution
- Worldwide distribution: USA, Canada, Greece, and Germany.
- Date initiated
- 2008-02-15
- Date posted
- 2008-09-11
- Date terminated
- 2011-02-15
- Location
- San Jose, CA
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