Siemens ONCOR Radiation Therapy Systems Recalled for Potential Dose Overdose
Siemens is recalling specific ONCOR radiation therapy systems due to a potential safety issue with dose monitoring interlocks that could result in a 10-20% overdose.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a significant injury risk (radiation overdose) without reported fatalities, meeting the criteria for a Severe rating.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling specific models of ONCOR radiation therapy systems, including the Avante Garde, Expression, Impression, and Impression Plus, when equipped with Digital LINAC Systems Control Console Software Versions 6, 7, 9, or 13. The recall involves 1,012 units distributed worldwide, with US consignees located in numerous states including Alabama, California, Florida, New York, and Texas.
The recall is being conducted due to a potential safety issue with the dose monitoring system safety interlocks. This defect could result in a 10-20% overdose of radiation therapy. The source text does not report any specific injuries or illnesses associated with this issue.
Healthcare facilities and consumers with these specific serial numbers should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the safety interlock issue.
The recalled product
- Product
- ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus #5857912 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 1,012
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 (20)
- Serial Numbers 3905
- 70-4077
- 4082
- 70-4283
- 70-4368
- 5177
- 3922
- 5120
- 5170
- 5179
- 5205
- 5226
- 5245
- 5282
- 5300
- 5343
- 5385
- 5391
- 5506
- 5665
Distribution
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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