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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Digital Capture System Ultra (SDC Ultra)

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 Class 2 Recall
Stryker Digital Capture System Ultra (SDC Ultra)
see related information
Date Posted September 11, 2008
Recall Status1 Open
Recall Number Z-1316-2008
Recall Event ID 46907
Product Classification Device, Digital Image Storage, Radiological - Product Code LMB
Product Stryker Digital Capture System Ultra (SDC Ultra), Model Number 240-050-988, Stryker Endoscopy, image and video archiving system.
Code Information Serial numbers 07H041654 - 08A069464, PP1.04
Recalling Firm/
Manufacturer
Stryker Endoscopy
5900 Optical Ct
San Jose, California 95138
Manufacturer 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 2
DESIGN: Software Design
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.
Quantity in Commerce 814 units distributed
Distribution Worldwide distribution: USA, Canada, Greece, and Germany.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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