Reported Apr 10, 2013 · Terminated
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE…
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?
- 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 3iPart No. 7341428Current R610/R630
- Product UsageThe 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
- Lot codes and dates
- All units of these models.
- Amount recalled
- 621 units (foreign account) in total
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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