Reported May 8, 2013 · Terminated

Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on…

Siemens Medical Solutions USA, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Siemens Medical Solutions USA, Inc · 757 Arnold Dr Ste A · Martinez, CA · 94553-3615

Is this the product you have?

  • 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.
Lot codes and dates
  • Syngo RT Therapist RTT 4.2.108
  • part number 8162815
    • Syngo ST Theratpist Connect RTT 4.2.108
    • part number 8168754
Amount recalled
245 active devices

Where it was sold

  • Nationwide

Why it was recalled

Software update to fix multiple safety related issues.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 12, 2013 · Data as of Sep 19, 6:51 PM UTC

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