Company: Stryker Endoscopy
Date of Enforcement Report 9/17/2008
Class:ll
PRODUCT
Stryker Digital Capture System Ultra (SDC Ultra), Model Number 240-050-988, Stryker Endoscopy, image and video archiving system, Recall # Z-1316-2008
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.
RECALLING FIRM/MANUFACTURER
Stryker Endoscopy, San Jose, CA, by letters dated February 14, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
814 units
DISTRIBUTION
Nationwide and Internationally
