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U.S. Department of Health and Human Services

Class 2 Device Recall SOMATOM Sensation Cardiac

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  Class 2 Device Recall SOMATOM Sensation Cardiac see related information
Date Initiated by Firm September 28, 2004
Date Posted November 03, 2004
Recall Status1 Terminated 3 on September 04, 2008
Recall Number Z-0160-05
Recall Event ID 30173
510(K)Number K013522  
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product SOMATOM CT System Sensation Cardiac, Computed Tomography X-Ray, Model Number 75 43 106
Code Information Serial Numbers: 52001, 52005, 52006, 52007, 52008, 52009, 52010, 52011, 52013, 52015, 52016, 52017, 52018, 52019, 52020, 52021, 52022, 52023, 52024, 52026, 52027, 52028, 52030, 52032, and 52033
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information Contact Roland Richter,
610-448-1777
Manufacturer Reason
for Recall		 Calcium Scoring feature on this devices is not closing properly after patient's exams.
FDA Determined
Cause 2		 Other
Action The recalling firm issued a Customer Safety Advisory with Update Instructions, CT036/04/S and CN048.04/2 to their affected customers. The letter informed the customers of the potential issue and provided instructions to avoid the problem while using this feature. A software upgrade is being developed to corect this issue.
Quantity in Commerce 25 units
Distribution The product was shipped to medical facilities nationwide and government account in IL.
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 = JAK and Original Applicant = SIEMENS MEDICAL SYSTEMS, INC.
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