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U.S. Department of Health and Human Services

Class 2 Device Recall Coroskop C XRay System

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  Class 2 Device Recall Coroskop C XRay System see related information
Date Initiated by Firm August 11, 2008
Date Posted November 04, 2008
Recall Status1 Terminated 3 on December 21, 2012
Recall Number Z-0141-2009
Recall Event ID 49426
510(K)Number K940484  
Product Classification angiographic x-ray system - Product Code IZI
Product Coroskop C X-Ray System, Model numbers 6005636 and 9108572.
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
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 24 units
Distribution Nationwide.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = IZI and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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