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Terminated

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

FDA Recall Z-1316-2008 · Posted 2008-09-11

Recalling FirmStryker Endoscopy
Recall StatusTerminated
Product CodeLMB
Date Initiated2008-02-15
Date Terminated2011-02-15
Product Quantity814 units distributed

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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