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Recall Observatory FDA recall evidence

Device 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.

Z-1182-2013

April 04, 2013

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 64944
Status
Terminated
Classification
Class II
Quantity
245 active devices
Official record key
device-enforcement:Z-1182-2013

Official wording

Reason: Software update to fix multiple safety related issues.

Code information: Syngo RT Therapist RTT 4.2.108; part number 8162815: Syngo ST Theratpist Connect RTT 4.2.108; part number 8168754

Distribution pattern: Worldwide Distribution - USA (nationwide) and internationally to Poland, India, Canada, Germany, United Kingdom, New Zealand, Belgium, Malaysia, Republic Korea, Ireland, Australia, Norway, Japan, Turkey, Croatia, Saudi Arabia, Colombia, P.R. China, Brazil, Thailand, Romania, Lebanon, Mexico, Italy, Sweden, Czech Republic, Russian Federation, and South Africa.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Software update to fix multiple safety related issues.