Date Initiated by Firm |
October 23, 2009 |
Date Posted |
May 10, 2010 |
Recall Status1 |
Terminated 3 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 CA 95138-1400
|
For Additional Information Contact |
408-754-2124
|
Manufacturer Reason for Recall |
Video device is not able to assign the correct time/date stamp.
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FDA Determined Cause 2 |
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
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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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