Date Initiated by Firm | April 25, 2016 |
Date Posted | June 15, 2016 |
Recall Status1 |
Terminated 3 on February 01, 2017 |
Recall Number | Z-2000-2016 |
Recall Event ID |
74239 |
510(K)Number | K123737 |
Product Classification |
System, tomography, computed, emission - Product Code KPS
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Product | BIOGRAPH mCT S(20) - 4R, MATERIAL NUMBER 10528958
Product Usage:
The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. |
Code Information |
Serial Number 11022 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA Inc. 810 Innovation Dr Knoxville TN 37932-2562
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For Additional Information Contact | see comments 865-218-2000 |
Manufacturer Reason for Recall | The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service. |
FDA Determined Cause 2 | Process design |
Action | Siemens sent a Customer Safety Advisory Letter to all affected customers. The letter identified the affected product, problem and actions to be taken. Siemens service organization will be contacting customers to schedule the update as per the attached Update Instruction and will be provided the replacement bracket to resolve the issue. For questions contact your Siemens representative. |
Quantity in Commerce | 1 unit |
Distribution | Worldwide Distribution - US Nationwide and the countries of China and Malaysia. |
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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