Company:Siemens Medical
Date of Enforcement Report 5/8/2013
Class ll:
PRODUCT
Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ONCOR and PRIMUS systems. ARTISTE, ONCOR and PRIMUS family of linear accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Recall Number Z-1182-2013
REASON
Software update to fix multiple safety related issues.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Martinez, CA on 4/4/2013 Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
245 active devices
DISTRIBUTION
Nationwide and Internationally
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