MAMMOMAT Revelation (2020-03-05)

Starting date:

March 5, 2020

Posting date:

April 15, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-72713

Last updated: 2020-04-15

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  Reason
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  Affected products

Affected Products

MAMMOMAT Revelation

Reason

Siemens has identified some quality issues with the biopsy paddles on the MAMMOMAT Revelation system. There is a potential for the biopsy plates to break when attached to a biopsy unit. The quality issues with the paddles were caused by processing conditions during manufacturing at the supplier. Siemens is releasing this update instruction to provide new biopsy paddles with improved mechanical stability.

Affected products