CLASS II Device recall · Reported 22 Feb 2017 · FDA Enforcement Report
Oncor Impression, Oncor Impression plus recalled
Siemens Medical Solutions USA is recalling Oncor Impression, Oncor Impression plus, and Oncor Expression Medical charged-particle. The recall was initiated on 25 Jan 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1214-2017
- FDA event ID
- 76454
- Recalling firm
- Siemens Medical Solutions USA, Malvern, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Jan 2017
- FDA classified
- 15 Feb 2017
- Reported
- 22 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 25 Jan 2017 | Recall initiated by company | |
| 15 Feb 2017 | Classified by FDA | +21 days |
| 22 Feb 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
ONCOR Impression, ONCOR Impression plus, and ONCOR Expression Medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer.
Where it was distributed
United States distribution
Questions about this recall
Is Oncor Impression, Oncor Impression plus, and Oncor Expression Medical charged-particle recalled?
Yes. Siemens Medical Solutions USA recalled Oncor Impression, Oncor Impression plus, and Oncor Expression Medical charged-particle on 25 Jan 2017. The recall is Class II and its status is Terminated. Recall number Z-1214-2017.
Why was it recalled?
Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension.
Which lots are affected?
Model Number: 5857920 Serial Numbers: 5377 3397 3986 5087 5093 70-4119 70-4144 70-4343 4078 5120 5170 5282 5506 70-4146 3855 5517 3422 3702 3751 3695 5364 3904 3781 5060 70-4316 5205 3383 3942 3981 4067 5157 5343 5844 3953 5148 5391 5300 3802 70-4143 70-4296 70-4235 5474 70-4363 70-4368 3791 3793 5833 5899 70-4378 3241 5355 3515 3574 3519 5281 5894 5374 5558 3225 3835 3367 3296 3591 3267 3679 3905 3922 3924 5367 3618 70-4354 70-4356 5540 3103 5488 3859 4019 5523 5350 5784 5821 70-4344 3979 3541 3413 3774 5843 3504 70-4129 5851 3354 3361 5098 3756 3305 3629 3136 5114 3748 5700 5410 70-4323 3666 3987 4036 3989 5865 3617 5118 5548 5861 5748 5222 3302 5737 5830 5245 5092 4021 5665 3815 5823 5088 3846 70-4178 70-4174 5353 70-4283 5630 70-4185 3639 3274 3761 5096 3801 3949 3878 3568 5572 3873 5417 5500 5388 70-4077 3547 5154 70-4287 70-4379 5226 3602 3657 3948 70-4135 3755 5601 5640 3622 5033 5177 3731 5707 5590 5657 70-4317 5398 4091 3644 4018 5532 70-4161 3114 3667 5424 3565 5755 5326 5525 5699 4082 70-4113 4015 5419 3998 3479 5481 5396 70-4347 4072 3939 5095 3901 5153 3244 5179
Where was it sold?
United States distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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