Mammomat Revelation (2020-05-11)

Starting date:

May 11, 2020

Posting date:

June 5, 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-73237

Last updated: 2020-06-05

• Reason
• 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. If an examination is interrupted when the inspect projection view (pv) is active and a vacuum biopsy system is being used, the tube arm can only be moved to a ±6° position by using the rotation buttons instead of the ±15° position that is possible with other projection views. A safetycustomer advisory notice will provide steps to the operator on how to diactivate the inspect functionality

Affected products