Devices

Device Recall ONCOR , PRIMUS HI, PRIMUS MidEnergy, MEVATRON M2, ARTISTE

Model / Serial
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 4059 5500 5388 3547 3678 3186 70-4362 70-4379 3804 3623 3453 3602 3657 3948 70-4135 3755 5033 3622 3731 2855 4065 4091 3644 4018 70-4306 3114 3565 3711 4015 3981 3998 3975 5093 5008 3939 5095 3901 5153 3244 5154
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
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.
Manufacturer
Siemens Medical Solutions USA, Inc
1 Event
- Recall of Device Recall ONCOR , PRIMUS HI, PRIMUS MidEnergy, MEVATRON M2, ARTISTE

Manufacturer

Siemens Medical Solutions USA, Inc

Manufacturer Address
Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355-1406
Manufacturer Parent Company (2017)
Siemens Ag
Source
USFDA

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