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XP003/20/P Mammomat Revelation AMC Box: Grey Images (2020-04-08) — recall 63404

Health Canada — Medical Devices · Canada · 2020-05-08 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
63404
Date of alert
2020-05-08
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/xp00320p-mammomat-revelation-a

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