| Class 2 Device Recall SOMATOM Sensation Cardiac | |
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
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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
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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 |
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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 = JAK
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