Reported Dec 21, 2022 · Ongoing
ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended…
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 · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
- ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3
- Material Number8162815
- Intended UseFamily of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer
- Lot codes and dates
- UDIN/A
- S/N
1073610737108221085010886108431086510025 Software version 4.3.1 MR3
- Amount recalled
- 8 units US
Where it was sold
Why it was recalled
When selecting the site fraction group for treatment, the User may select the wrong site for treatment, and potentially deliver the dose to wrong isocenter
This product could cause temporary or reversible health problems — stop using it.
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