FDA Device recall Z-1059-2015
LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, Mevatron M2/Primus Mi…
- FDA Device
- Class II
- terminated
- Published 2015-02-11
On 2015-02-11 the FDA classified a Class II recall of LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, Mevatron M2/Primus Mi… by Siemens Medical Solutions Usa, citing 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 sign….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1059-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-19 |
| Published | 2015-02-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
LINAC Accelerators: ARTISTE, 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 Usage: 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
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.
Identifiers
| code_info | model numbers: 08139789, 05863472, 05857912, 07360717, 05857920, 04504200, 01940035, 05500371, 09822685, 09411588, 09…model numbers: 08139789, 05863472, 05857912, 07360717, 05857920, 04504200, 01940035, 05500371, 09822685, 09411588, 09822693, 08515520, 01940753, 01924500, 09401506, 09401407, 09401316, 09401746, 09401654, with serial numbers: 3397 3986 5087 70-4119 70-4144 70-4262 70-4343 4078 5120 5170 5282 5506 70-4146 5527 2958 3855 5517 3753 3702 3751 2863 3695 5364 3904 70-4287 70-4175 3102 3781 3203 5060 3798 70-4316 5205 3383 5688 5743 3832 2972 3942 70-4122 4067 70-4283 5190 5157 2646 5343 5844 3953 5148 5391 3931 5300 3802 70-4172 70-4143 70-4296 3079 2516 70-4235 2962 70-4257 5474 2834 70-4363 70-4368 3791 3793 3738 3817 3055 5833 5899 2586 5207 3458 3673 70-4378 5355 3515 70-4159 3524 3574 3519 5281 5894 5374 5558 3225 3631 3835 3367 3296 2702 3591 3267 2912 3905 3922 3924 2896 2814 3773 3679 3533 3709 5367 3618 70-4354 70-4356 5540 3103 5488 3859 3009 4019 5523 5590 5657 |
|---|
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-1059-2015%22
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