Siemens Medical Solutions Recalls MEVATRON Radiation Therapy Systems
Siemens Medical Solutions is recalling specific MEVATRON radiation therapy systems due to a potential safety issue with dose monitoring interlocks that could result in a 10-20% radiation 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 (10-20% radiation overdose), which aligns with the rubric criteria for a Severe (4) rating.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling specific models of MEVATRON radiation therapy systems, including the M2/Primus Mid-Energy, PRIMART, KD-2, KD2, M-2 6740, MD-2, and MDX-2. The recall affects units equipped with Digital LINAC Systems Control Console Software Versions 6, 7, 9, or 13. A total of 1,012 units are involved in this recall.
The recall is being conducted because of a potential safety issue with the dose monitoring system safety interlocks. This defect could result in a 10-20% overdose of radiation therapy for patients. The affected units have been distributed worldwide, with US consignees located in 34 states and Puerto Rico.
Healthcare facilities and consumers who possess these specific serial numbers should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the safety interlock issue. The source text does not specify a particular action for end-users other than the recall notification.
The recalled product
- Product
- MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2 #01940753, MEVATRON M-2 6740 #09401506, MEVATRON MD-2 #09401654, MEVATRON MDX-2 #09401746 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 2507
- 2516
- 2596
- 2689
- 2818
- 2962
- 3013
- 3103
- 3089
- 3136
- 2855
- 3296
- 3397
- 3591
- 3629
- 3639
- 3644
- 3702
- 3873
- 3939
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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