Recall record at a glance
| Official record | Z-0980-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Report date | Jan 21, 2015 |
| Recall initiation date | Dec 2, 2014 |
| Quantity | 320 |
| Location | Malvern, PA, United States |
Official product description
Siemens Linear Accelerator: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON M2 6740, MEVATRON M2 6700, MEVATRON 6300, MEVATRON MDX-2, MEVATRON MD-2, MEVATRON KD, MEVATRON KDS, MEVATRON 77, MEVATRON K7467, MEVATRON 7767, MEVATRON K8067, MEVATRON M 6300 (MX), MEVATRON M 6730, MEVATRON M 7140, MEVATRON M 7400, MEVATRON MDX, MEVATRON MD (MD, MDX), 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.
Why the product 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.
Distribution information
Worldwide Distribution - US Nationwide including Canada and Mexico.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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