MAMMOMAT Inspiration Full field digital mammographic x-ray system

FDA device recall Z-0523-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc

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

Action taken

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.

Root cause

Use error

Status

Terminated

Product code

MUE

Quantity affected

12

Distribution

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

Date initiated

2011-09-15

Date posted

2012-01-11

Date terminated

2014-03-05

Location

Malvern, PA