Siemens ARTISTE MV System Recalled for Radiation Dose Monitoring Safety Interlock Defect
Siemens is recalling ARTISTE MV Systems due to a potential safety issue with dose monitoring interlocks that could result in a 10-20% radiation therapy 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 defect that could result in a 10-20% radiation therapy overdose, which constitutes a significant injury risk.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, and 13. The recall involves 1,012 units distributed worldwide, with US consignees located in 34 states and Puerto Rico.
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. The affected units are identified by specific serial numbers listed in the recall documentation.
Healthcare facilities and consumers with these specific systems should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the safety interlock issue.
The recalled product
- Product
- ARTISTE MV System Model #8139789 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 5350
- 5410
- 5419
- 5481
- 5500
- 5488
- 5532
- 5540
- 5548
- 5572
- 5590
- 5601
- 5630
- 5640
- 5657
- 5699
- 5707
- 5737
- 5743
- 5748
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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