Reported Feb 11, 2015 · Terminated
LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI,…
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 · 51 Valley Stream Pkwy · Malvern, PA · 19355-1406
Is this the product you have?
- LINAC AcceleratorsARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON KDS-2, MEVATRON KD-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON M2 6740, MEVATRON M2 6700, MEVATRON M2 6300, MEVATRON MDX-2, MEVATRON MD-2; The intended use of the MEVATRON, PRIMUS, ONCOR and ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer
- Product UsageThe intended use of the MEVATRON, PRIMUS, ONCOR and ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer
- Lot codes and dates
- model numbers
08139789058634720585791207360717058579200450420001940035055003710982268509411588098226930851552001940753019245000940150609401407094013160940174609401654
- with serial numbers
310 of 310 codes
33973986508770-411970-414470-426270-43434078512051705282550670-41465527295838555517375337023751286336955364390470-428770-41753102378132035060379870-4316520533835688574338322972394270-4122406770-42835190515726465343584439535148539139315300380270-417270-414370-42963079251670-42352962
- model numbers
- Amount recalled
- 310
Where it was sold
- Nationwide
Why it was recalled
A hardware update to replace the old PCB Assembly, Head Driver-G41 with PCB with overcurrent protection as a result of reports of the electric board inside the gantry showing signs of overheating, including thermal damage and smoke emission.
This product could cause temporary or reversible health problems — stop using it.
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