Reported Jun 26, 2013 · Terminated
ARTISTE with syngo RT Therapist version 4.3 Product Usage: The intended use of the SIEMENS branded ARTISTE family of…
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?
- ARTISTE with syngo RT Therapist version 4.3
- Product UsageThe intended use of the SIEMENS branded ARTISTE 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 the version 4.3Part No. 08162815
- Amount recalled
- 8 units
Why it was recalled
The potential for a safety issue, for the image quality degradation, that is addressed by the Customer Safety Advisory Notice when verifying the patient position based on 2D images that were acquired as single-exposure MV or In-Line kView images using the syngo RT Therapist 4.3.
This product could cause temporary or reversible health problems — stop using it.
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