CLASS II Device recall · Reported 10 Apr 2013 · FDA Enforcement Report

Siemens Coherence RT Therapist versions Rtt MR1.5 recalled

Siemens Medical Solutions USA is recalling Siemens Coherence RT Therapist versions Rtt MR1.5, Rtt 1/2.1A and Rtt 2/ 2B. The recall was initiated on 5 Mar 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll units of these models.

Quantity recalled621 units (foreign account) in total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1044-2013
FDA event ID: 64675
Recalling firm: Siemens Medical Solutions USA, Martinez, CA
Classification: Class II
Status: Terminated
Recall initiated: 5 Mar 2013
FDA classified: 1 Apr 2013
Reported: 10 Apr 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

5 Mar 2013	Recall initiated by company
1 Apr 2013	Classified by FDA	+27 days
10 Apr 2013	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: Primeview 3i 2.0, Part No. 8139847, Current R630; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

Where it was distributed

Worldwide Distribution

Questions about this recall

Is Siemens Coherence RT Therapist versions Rtt MR1.5, Rtt 1/2.1A and Rtt 2/ 2B recalled?

Yes. Siemens Medical Solutions USA recalled Siemens Coherence RT Therapist versions Rtt MR1.5, Rtt 1/2.1A and Rtt 2/ 2B on 5 Mar 2013. The recall is Class II and its status is Terminated. Recall number Z-1044-2013.

Why was it recalled?

Which lots are affected?

All units of these models.

Where was it sold?

Worldwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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