—#68462

Product

Stryker Digital Capture System Ultra (SDC Ultra), Model Number 240-050-988, Stryker Endoscopy, image and video archiving system.

FDA product code: LMB — Device, Digital Image Storage, Radiological
Device class: Class 1
Medical specialty: Radiology
Affected lot / code info: Serial numbers 07H041654 - 08A069464, PP1.04

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Stryker Endoscopy
Address: 5900 Optical Ct, San Jose, California 95138

Distribution

Distribution pattern: Worldwide distribution: USA, Canada, Greece, and Germany.

Timeline

Recall initiated: 2008-02-15
Posted by FDA: 2008-09-11
Terminated: 2011-02-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #68462. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.