Company:Siemens Medical Solutions USA, Inc
Date of Enforcement Report 4/25/2018
Class lI:

PRODUCT

MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Recall Number: Z-1397-2018

REASON
Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 2/14/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
18

DISTRIBUTION
Nationwide, PR and Nassau

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