Reported Jan 21, 2015 · Terminated
Siemens Linear Accelerator: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression,…
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?
- Siemens Linear Accelerator
ARTISTEONCOR Avant GardeONCOR Impression PlusONCOR ExpressionONCOR ImpressionPRIUS HIMevatron M2/Primus Mid-EnergyMEVATRON PRIMARTMEVATRON KD-2MEVATRON KDS-2MEVATRON K2MEVATRON 6323-2MEVATRON M2 6740MEVATRON M2 6700MEVATRON 6300MEVATRON MDX-2MEVATRON MD-2MEVATRON KDMEVATRON KDSMEVATRON 77MEVATRON K7467MEVATRON 7767MEVATRON K8067MEVATRON M 6300 (MX)MEVATRON M 6730MEVATRON M 7140MEVATRON M 7400MEVATRON MDXMEVATRON MD (MDMDX)MEVATRON M 7445 (MXE)MEVATRON M 7400/7440 (MXE)MEVATRON M 6730/6740 (MXE)
- MEVATRON M 6700 (MX)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
- Lot codes and dates
- Name and Model Number of deviceARTISTE - 08139789 ONCOR Avant-garde - 05863472 ONCOR Impression Plus - 05857912 ONCOR Expression - 07360717 ONCOR Impression - 05857920 PRIUS HI - 04504200 Mevatron M2/Primus Mid-Energy 01940035 MEVATRON PRIMART - 05500371 MEVATRON KD-2 - 09822685 MEVATRON KDS-2 - 09411588 MEVATRON KDS-2 - 09822693 MEVATRON K2 - 08515520 MEVATRON 6323-2 - 01924500 MEVATRON M2 6740 - 09401506 MEVATRON M2 6700 - 09401407 MEVATRON 6300 - 09401316 MEVATRON MDX-2 - 09401746 MEVATRON MD-2 - 09401654 MEVATRON KD - 08319857 MEVATRON KDS - 09401522 MEVATRON 77 - 05659503 MEVATRON K7467 - 05694252 MEVATRON K7767 - 05694302 MEVATRON K8067 - 05694401 MEVATRON M 6300 (MX) - 08317000 MEVATRON M 6730 - 05694005 MEVATRON M 7140 - 05694104 MEVATRON M 7400 - 05694153 MEVATRON MDX - 08496200 MEVATRON MD (MD, MDX) - 08319808 MEVATRON M 7445 (MXE) - 05694203 MEVATRON M 7400/7440 (MXE) 05672977 MEVATRON M 6730/6740 (MXE) 08319758 MEVATRON M 6700 (MX) - 05693908
- US Serial numbers3397, 3986, 5087, 70-4119, 70-4144, 70-4262, 70-4343, 4078, 5120, 5170, 5282, 5506, 70-4146, 3287, 5527, 2958, 3855, 5517, 3753,
302 of 302 codes
37023751286336955364390470-428770-41753102378132035060379870-4316520533835688574338322972394270-4122406770-428351905157264653435844395351485391393153005300380270-417270-414370-42963079251670-4235296270-42575474283470-436370-43683791379337383817305558335899258652073458367370-4378
- ROW Serial Numbers
758 of 758 codes
70-4217349670-422170-4226280129753312331733893493404570-4373249525012551255225592566261926272674267726822709272827372741274827552789280928212822283128522868287928812884288628952926294629472953296929712983300630513054305630633065308330883096313931523164
- Amount recalled
- 320
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Use of any unauthorized third-party components on Siemens LINACs may lead to patient or operator injury, damage to the LINAC, and can potentially compromise customer warranty. The dark current dose must be considered in the overall dose calculation, or an overdose and serious injury may occur.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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