| | Class 2 Device Recall Coroskop C XRay System |  |
| Date Initiated by Firm | August 11, 2008 |
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| Date Posted | November 04, 2008 |
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| Recall Status1 |
Terminated 3 on December 21, 2012 |
| Recall Number | Z-0141-2009 |
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| Recall Event ID |
49426 |
| 510(K)Number | K940484 |
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| Product Classification |
angiographic x-ray system - Product Code IZI
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| Product | Coroskop C X-Ray System, Model numbers 6005636 and 9108572. |
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| Code Information |
Model number 6005636 - Serial numbers: 2001, 2013, 2063, 2064, 2065, 2066, 2069, 2150, 2151, 2168, 2186, 2197, 2203, 2206, 2210, 2222, 2226, 2240, 2252, and 2265. Model number 9108572 - Serial numbers: 2147, 2150, 2203, and 2275. |
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. |
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FDA Determined
Cause 2 | Software design |
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| 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. |
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| Quantity in Commerce | 24 units |
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| Distribution | Nationwide. |
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| 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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