| Class 2 Device Recall Siemens MAMMOMAT Inspiration | |
Date Initiated by Firm | September 15, 2011 |
Date Posted | January 11, 2012 |
Recall Status1 |
Terminated 3 on March 05, 2014 |
Recall Number | Z-0523-2012 |
Recall Event ID |
60423 |
PMA Number | P030010S006 |
Product Classification |
Full field digital,system,x-ray,mammographic - Product Code MUE
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Product | MAMMOMAT Inspiration
Full field digital mammographic x-ray system |
Code Information |
Model number 10140000 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 51 Valley Stream Pkwy Malvern PA 19355
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For Additional Information Contact | Anastasia Mason 610-219-4834 |
Manufacturer Reason for Recall | Lowering the swivel arm with "object table" while an operator's or patient's body parts are underneath the "object table" may cause the "object table" to collide with and injure the operator or patient. Therefore attention should be paid when adjusting "object table" height to avoid a possible risk of injury to the operator or the patient.
The movement of the swivel arm may also cause an injur |
FDA Determined Cause 2 | Use error |
Action | Siemens Medical Solutions USA, Inc sent a Safety Advisory Notice dated January 8, 2011, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer.
The notification included an Addendum to the User Manual.
We appreciate your understanding and cooperation with this safety advisory and ask you to immediately instruct your operating personnel accordingly. Please ensure that this safety advisory is placed in the System's Operator Manual. Your operating personnel should maintain awareness over an appropriate defined period.
Further questions please call (610) 219-4834. |
Quantity in Commerce | 12 |
Distribution | Nationwide Distribution including the states of FL, MD, MI, NE, NY, NC, ND, OH, and SC. |
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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PMA Database | PMAs with Product Code = MUE
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