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Terminated

Mammomat Inspiration system: Product Usage: mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.

FDA Recall Z-0523-2015 · Posted 2014-12-06

Recall StatusTerminated
Product CodeMUE
Date Initiated2014-10-28
Date Terminated2015-07-20
Product Quantity3

Reason for Recall

It was determined that if the Mammomat Inspiration system is not secured to the floor (per customer request) and monitors are positioned too far from the table top, there is a potential risk that the Acquisition Workstation (AWS) table may become unstable and fall over. This may result in a serious injury to the operator.

Firm Action

A safety advisory notice, dated October 28, 2014, was sent to users that identified the product, problem, and actions to be taken to prevent risk to patients and users. Siemens technicians werre instructed to contact customers to schedule a field modification.

Root Cause

Use error

Distribution Pattern

US Nationwide Distribution in the state of: WV, NY, and FL..

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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