Date Initiated by Firm | July 14, 2015 |
Date Posted | August 05, 2015 |
Recall Status1 |
Terminated 3 on March 03, 2016 |
Recall Number | Z-2336-2015 |
Recall Event ID |
71712 |
510(K)Number | K123737 |
Product Classification |
System, tomography, computed, emission - Product Code KPS
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Product | Biograph 6-4R TruePoint w/ TrueV, Model Number 10097290 |
Code Information |
SERIAL NUMBER 45590 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA Inc. 810 Innovation Dr Knoxville TN 37932-2562
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For Additional Information Contact | Service representatives 865-218-2000 |
Manufacturer Reason for Recall | Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring. |
FDA Determined Cause 2 | Packaging change control |
Action | The firm initiated their recall on 07/14/2015 by telephone to the sole US consignee. The update is scheduled for 07/15/2015. |
Quantity in Commerce | 1 unit |
Distribution | Distributed in the state of Texas and the countries of Germany, France, Russia, Denmark, and Switzerland. |
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 = KPS
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