Siemens Recalls ONCOR Radiation Therapy Systems Due to Collimator and Weld Defects
Siemens is recalling 194 ONCOR radiation therapy systems in the US due to incorrect collimator position displays and improper weld seams.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device (radiation therapy system) with defects that could lead to improper treatment delivery or structural failure, but the source text does not report any injuries, illnesses, or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 194 units of the ONCOR Impression, ONCOR Impression plus, and ONCOR Expression Medical charged-particle radiation therapy systems. These systems are intended to deliver x-ray radiation for the therapeutic treatment of cancer. The recall covers units distributed in the United States.
The recall was initiated because Siemens became aware of incorrect values for the rotational collimator position displayed on the systems. This issue is attributed to mechanical problems with the sensor slide. Additionally, the source text notes that there are improper weld seams at the overhead suspension of the affected units.
Healthcare facilities and users of these specific systems should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the recall and necessary corrective actions.
The recalled product
- Product
- 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 cance
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 194
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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