The Recall Desk
SevereFDA (Devices)·Z-1638-2014·Announced 2014-05-28

Siemens MAMMOMAT Inspiration PC Monitor Holder Recall for Injury Risk

Siemens is recalling five MAMMOMAT Inspiration mammography units because the PC monitor holder can break, causing the monitor to fall and potentially injure users.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states that the defect can cause 'possible serious injury,' which aligns with the rubric criterion for a score of 4 (Severe) involving significant injury reports or risks.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling five MAMMOMAT Inspiration mammography units. The recall is due to a potential hazard where the holder of the PC monitor at the control desk can break. If the holder breaks, the monitor may become unstable and fall, which could cause serious injury to the user.

The affected units are identified by material number 10549894 with serial numbers ranging from 5000 through 5029. These devices were distributed in the states of Georgia, Florida, New York, Nevada, and Massachusetts. The MAMMOMAT Inspiration is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals.

The FDA has classified this as a Class II recall. Consumers and medical facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the defect.

The recalled product

Product
MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals.
Affected units
5

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

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

Distribution

Distributed in 5 states:

Same manufacturer · Siemens Medical Solutions USA, Inc

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