FDA Device recall Z-0168-2016
ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, MEVATRON M2/PRIMUS Mid-Energy, ARTISTE
- FDA Device
- Class II
- terminated
- Published 2015-11-04
On 2015-11-04 the FDA classified a Class II recall of ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, MEVATRON M2/PRIMUS Mid-Energy, ARTISTE by Siemens Medical Solutions Usa, citing potential safety risk of collision of the LINAC gantry with the patient or the treatment table in case of automatically sequenced treatment delivery techniques using SIMTEC" Auto….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0168-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-05 |
| Published | 2015-11-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, MEVATRON M2/PRIMUS Mid-Energy, ARTISTE; intended use is to deliver x-ray radiation for therapeutic treatment of cancer.
Reason
potential safety risk of collision of the LINAC gantry with the patient or the treatment table in case of automatically sequenced treatment delivery techniques using SIMTEC" Auto Field Sequence Option.
Identifiers
| code_info | model numbers: ONCOR Avant-garde - 05863472 ONCOR Impression Plus - 05857912 ONCOR Expression - 07360717 ONCOR Impre…model numbers: ONCOR Avant-garde - 05863472 ONCOR Impression Plus - 05857912 ONCOR Expression - 07360717 ONCOR Impression - 05857920 PRIMUS HI - 04504200 MEVATRON M2/PRIMUS Mid-Energy 01940035 ARTISTE - 08139789 with serial numbers: 3986 3855 2958 3753 3751 70-4287 3781 5060 3203 3798 70-4316 3383 3832 3942 4067 5844 3953 5148 3802 70-4172 70-4143 70-4296 70-4235 70-4257 5474 70-4368 70-4363 3738 3817 3791 3793 5207 3458 3673 3241 3524 3574 3519 3225 3835 3367 3296 3591 3905 3922 3924 3773 3679 3533 3618 70-4356 5540 3103 5488 3859 4019 5821 3503 70-4344 3285 3979 3413 3774 3318 70-4183 3888 3361 5098 5385 3756 3305 3604 3629 3136 3788 70-4323 3666 3825 70-4207 4036 70-4166 3617 3736 3842 70-4188 5861 5222 3484 3302 3068 5656 5245 5092 3778 5088 3303 4021 3245 5665 3815 3133 3846 3907 70-4174 3534 5353 70-4185 3639 3274 3664 3801 3878 3949 2894 5572 3699 5417 40 |
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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-0168-2016%22
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