15
Apr
2020

Recall – Radiation therapy software error could result in overdose

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0

Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 4/15/2020
Class II

PRODUCT

ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13

  • Recall Number: Z-1677-2020

REASON

Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.

RECALLING FIRM/MANUFACTURER

Siemens Medical Solutions USA, Inc on 2/18/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

1012

DISTRIBUTION

US Nationwide and International

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