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Terminated

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

FDA Recall Z-1638-2014 · Posted 2014-05-20

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeMUE
Date Initiated2014-04-25
Date Terminated2014-12-15
Product Quantity5

Reason for Recall

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.

Firm Action

A safety advisory notice, dated April 25, 2014, was sent to direct accounts to notify them of the issue and provide instructions to avoid the potential risk of injury.

Root Cause

Device Design

Distribution Pattern

Distributed in the states of GA, FL, NY, NV, and MA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K122286MAMMOMAL INSPIRATIONSiemens Medical Solutions USA, Inc. · 2013-02-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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