Siemens Oncor Avant-garde Radiation Therapy Systems Recalled for Sensor Defects
Siemens is recalling 194 Oncor Avant-garde radiation therapy systems 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 medical device used for cancer treatment with mechanical defects that could impact treatment accuracy. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 194 units of the ONCOR Avant-garde medical charged-particle radiation therapy system. The recall affects systems distributed in the United States with specific model and serial numbers listed in the agency record.
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.
The intended use of these systems is to deliver x-ray radiation for the therapeutic treatment of cancer. Consumers and healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the recall and necessary corrective actions.
The recalled product
- Product
- ONCOR Avant-garde, 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.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 194
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number: 5863472
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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