FDAClass IIMay 28, 2014

MAMMOMAT Inspiration. Intended for mammography exams recall

MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals.

Why was MAMMOMAT Inspiration. Intended for mammography exams recalled?

There is a potential and possible hazard to the user when using the MAMMOMAT Inspiration PC monitor at the control desk, in that the holder of the PC monitor can break causing an unstable monitor to fall causing possible serious injury.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

(Material number 10549894) with serial numbers 5000 through 5029.

Product
MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals.
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
5
Distribution
Distributed in the states of GA, FL, NY, NV, and MA.
Recall date
May 28, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls