FDA Device recall Z-0980-2015
Siemens Linear Accelerator: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIUS HI, Mevatron M2/Pr…
- FDA Device
- Class II
- terminated
- Published 2015-01-21
On 2015-01-21 the FDA classified a Class II recall of Siemens Linear Accelerator: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIUS HI, Mevatron M2/Pr… by Siemens Medical Solutions Usa, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0980-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-02 |
| Published | 2015-01-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | Name and Model Number of device: ARTISTE - 08139789 ONCOR Avant-garde - 05863472 ONCOR Impression Plus - 05857912…Name and Model Number of device: ARTISTE - 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) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0980-2015%22
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