| Class 2 Device Recall Coroskop Top XRay System | |
Date Initiated by Firm | August 11, 2008 |
Date Posted | November 04, 2008 |
Recall Status1 |
Terminated 3 on December 21, 2012 |
Recall Number | Z-0140-2009 |
Recall Event ID |
49426 |
510(K)Number | K940484 |
Product Classification |
angiographic x-ray system - Product Code IZI
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Product | Coroskop Top X-Ray System, Model number 6134808. |
Code Information |
Model number 6134808. Serial numbers: 4502, 4508, 4518, 4520, 4521, 4532, 4543, 4547, 4552, 4565, and 4570. |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 51 Valley Stream Pkwy Malvern PA 19355
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Manufacturer Reason for Recall | Unintended movement of the system table and/or C arm. |
FDA Determined Cause 2 | Software design |
Action | Siemens Medical Solutions issued a letter to consignees on 8/11/2008 to inform them of the problem and a workaround should the issue occur prior to software revision. |
Quantity in Commerce | 11 units |
Distribution | Nationwide. |
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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510(K) Database | 510(K)s with Product Code = IZI
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