—#105375

Product

MAMMOMAT Inspiration Full field digital mammographic x-ray system

FDA product code: MUE — Full Field Digital, System, X-Ray, Mammographic
Device class: Class 2
Medical specialty: Radiology
PMA numbers: P030010S006
Affected lot / code info: Model number 10140000

Why it was recalled

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

Root cause (FDA determination)

Use error

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: Nationwide Distribution including the states of FL, MD, MI, NE, NY, NC, ND, OH, and SC.

Timeline

Recall initiated: 2011-09-15
Posted by FDA: 2012-01-11
Terminated: 2014-03-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #105375. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.