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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens MAMMOMAT Inspiration

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 Class 2 Recall
Siemens MAMMOMAT Inspiration
see related information
Date Posted January 11, 2012
Recall Status1 Terminated on March 05, 2014
Recall Number Z-0523-2012
Recall Event ID 60423
Premarket Approval
PMA Number
P030010
Product Classification Full Field Digital,System,X-Ray,Mammographic - Product Code MUE
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, Pennsylvania 19355
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
TRAINING: 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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = MUE and Applicant = SIEMENS MEDICAL SOLUTION
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