Date Initiated by Firm | September 18, 2014 |
Date Posted | October 17, 2014 |
Recall Status1 |
Terminated 3 on February 24, 2015 |
Recall Number | Z-0086-2015 |
Recall Event ID |
69371 |
510(K)Number | K122286 |
Product Classification |
Full field digital,system,x-ray,mammographic - Product Code MUE
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Product | Siemens Mammomat Inspiration mammography systems.
The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation. |
Code Information |
material #10140000, with serial numbers: 5018 3849 5042 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 51 Valley Stream Pkwy Malvern PA 19355
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For Additional Information Contact | Customer Support 610-219-6300 |
Manufacturer Reason for Recall | The stereo biopsy devices for Mammomat Inspiration mammography systems might have integrated a safety switch which causes a failure of the functionality. The pin implemented in the safety switch may not put enough pressure on the safety circuit to prohibit movement. The needle positioning device may move even with the safety switch being set sideward. If this occurs with the needle being already i |
FDA Determined Cause 2 | Process control |
Action | A safety advisory notice, dated September 18, 2014, was sent to end users that identified the product, problem, and actions to be taken. |
Quantity in Commerce | 3 |
Distribution | US Distribution in states of: NY, VA, and MA. |
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 = MUE
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