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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 Device Recall Stryker Digital Capture System Ultra (SDC Ultra)see related information
Date Initiated by FirmFebruary 15, 2008
Date PostedSeptember 11, 2008
Recall Status1 Terminated 3 on February 15, 2011
Recall NumberZ-1316-2008
Recall Event ID 46907
Product Classification image and video archiving system. - Product Code LMB
ProductStryker 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
FEI Number 2936485
Recalling Firm/
Manufacturer		 Stryker Endoscopy
5900 Optical Ct
San Jose CA 95138
For Additional Information Contact
408-754-2124
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		Software design
ActionStryker 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 Commerce814 units distributed
DistributionWorldwide distribution: USA, Canada, Greece, and Germany.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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