MAMMOMAT Revelation (2019-07-26)

Starting date:

July 26, 2019

Posting date:

August 9, 2019

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-70671

Last updated: 2019-08-09

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  Reason
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  Affected products

Affected Products

MAMMOMAT Revelation

Reason

Siemens Healthineers has become aware of an error that can occur when performing a biopsy using the inspect function. The acquisition workstation may become unresponsive to normal user interaction. If this happens, it may become difficult to release the patient from the system following standard workflow steps. In this case, the manual removal of the biopsy needle is needed. A safety advisory notice is released to provide steps to the operator on how to easily release patient and proceed with exam. Siemens is also providing a software solution to resolve the issue.

Affected products