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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Endoscopy SDC HD and SCD HDi

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 Class 2 Recall
Stryker Endoscopy SDC HD and SCD HDi
see related information
Date Posted May 10, 2010
Recall Status1 Terminated on February 17, 2011
Recall Number Z-1590-2010
Recall Event ID 54683
Product Classification Device, Digital Image Storage, Radiological - Product Code LMB
Product An Imaging device for medical procedures, to provide surgeons or operating room personnel the ability to capture still images and to record video during the surgical procedures in various file formats. Images can be transferred to external media.
Code Information Product Name: SDC HD units and SDC HDi units Model Nuumbers: 240-050-888 and 240-050-888i Code: All SDC HD and SDC HDi units
Recalling Firm/
Manufacturer
Stryker Endoscopy
5900 Optical Ct
San Jose, California 95138-1400
Manufacturer Reason
for Recall
Video device is not able to assign the correct time/date stamp.
FDA Determined
Cause 2
DESIGN: Device Design
Action Stryker Endoscopy has notified the 2865 domestic consignees affected by the device correction. The notification was mailed to affected consignees and their corresponding sales representatives. It included two mailings of the Urgent: Device Correction notice, SDC HD 3.0z correction software, and a SDC HD upgrade dongle. 100% of consignees have been contacted and notified of the device correction needed. The effectiveness of the correction has been tracked via acknowledgement cards mailed, faxed, or emailed. The local Stryker Sales Representative will install a software upgrade to fix this issue. Additional questions should be directed to the firm's Customer Service at (800)624-4422 or (408)754-2039.
Quantity in Commerce 12896 devices
Distribution US government facilities and other US domestic consignees(nationwide), and to foreign countries
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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