Reported Jan 5, 2022 · Terminated
ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the…
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 with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer
- Model Number8162815
- Lot codes and dates
- Serial Numbers
10085105241073710736105861079210793108221084310850108861086511122
- UDI040568691613655911
- Serial Numbers
- Amount recalled
- 13 units
Where it was sold
Why it was recalled
Potential safety issue under specific preconditons that may result in a user selecting the wrong site for treatment with the possibility to deliver dose to the wrong isocenter which could result in serious patient injury
This product could cause temporary or reversible health problems — stop using it.
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