FDAClass IIOctober 29, 2014

Siemens Mammomat Inspiration mammography systems. The recall

Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and…

Why was Siemens Mammomat Inspiration mammography systems. The recalled?

The stereo biopsy devices for Mammomat Inspiration mammography systems might have integrated a safety switch which causes a failure of the functionality. The pin implemented in the safety switch may not put enough pressure on the safety circuit to prohibit movement. The needle positioning device may move even with the safety switch being set sideward. If this occurs with the needle being already i

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 #10140000, with serial numbers: 5018 3849 5042

Product
Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
3
Distribution
US Distribution in states of: NY, VA, and MA.
Recall date
October 29, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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