Siemens PRIMUS HI Linear Accelerators Recalled for Radiation Overdose Risk
Siemens is recalling PRIMUS HI linear accelerators because a safety interlock defect could cause a 10-20% overdose of radiation therapy.
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 risk of harm (10-20% radiation overdose) to patients, which aligns with the 'Severe' criteria for significant injury reports or high-risk medical device defects.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling approximately 230,001 units of PRIMUS HI #04504200 linear accelerators equipped with Digital LINAC Systems Control Console Software Versions 6, 7, 9, or 13. The recall is due to a potential safety issue with the dose monitoring system safety interlocks.
The defect could result in a 10-20% overdose of radiation therapy. The affected devices were distributed worldwide, with US consignees located in 34 states and Puerto Rico. Specific serial numbers are listed in the agency's recall documentation.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the safety interlock issue. Patients who received treatment on these devices should consult their healthcare provider regarding the potential impact of the dose variance.
The recalled product
- Product
- PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 230,001
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 3025
- 3049
- 3241
- 3267
- 3305
- 3422
- 3479
- 3515
- 3519
- 3547
- 3565
- 3602
- 3731
- 3751
- 3832
- 3667
- 3924
- 3949
- 4036
- 70-4185
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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