—#136546

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.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K031764, K060226, K142434, K993425
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

Siemens sent Safety Advisory Notices, dated May 5th and 22nd, 2015 to all affected customers to inform them about an update of the Control Console software to correct defects affecting the Control Console with their digital Linear Accelerator. Customers were instructed to ensure everne at their organization is aware of the information in the Advisory Notice. If product was further distributed, please forward Safety Notice to all those affected. For questions regarding this recall call 610-219-6300.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2015-05-05
Posted by FDA: 2015-10-27
Terminated: 2017-05-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #136546. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.