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ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, MEVATRON...

FDA Device Recall #Z-0168-2016 — Class II — May 5, 2015

Recall Summary

Recall Number Z-0168-2016
Classification Class II — Moderate risk
Date Initiated May 5, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Siemens Medical Solutions USA, Inc
Location Malvern, PA
Product Type Devices
Quantity 158

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.

Reason for Recall

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.

Distribution Pattern

Nationwide Distribution

Lot / Code Information

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

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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