XP003/20/P Mammomat Revelation AMC Box: Grey Images (2020-04-08)

Starting date:

April 8, 2020

Posting date:

May 8, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-72993

Last updated: 2020-05-08

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  Reason
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  Affected products

Affected Products

XP003/20/P Mammomat Revelation AMC Box: Grey Images

Reason

Siemens has identified some issues with the AMC box on the multitom rax unit. The system sporadically produces grey images that are being generated via the one-point technique. The issue is caused by an AMC box (automatic exposure control multic converter). A new revision level of the AMC box is being implemented. It contains a change of the power supply and implementation of an additional pull-down resistor. Siemens is releasing this update instruction to provide new amc box to resolve the issue of sporadically generated grey images.

Affected products