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
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
XP003/20/P Mammomat Revelation AMC Box: Grey Images
Lot or serial number
11017
Model or catalog number
10860700
Companies
- Manufacturer
-
Siemens Healthcare GMBH
Henkestr. 127
Erlangen
91052
GERMANY