Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report 10/5/2016
Class lI:
PRODUCT
Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording
Recall Number Z-2878-2016
REASON
Software patch installation to address several safety issues
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA on 9/23/2016 Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
103 accelerators
DISTRIBUTION
Nationwide
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