Siemens LANTIS Oncology Servers Recalled for Potential Treatment Errors
Siemens is recalling 87 LANTIS Oncology Information System servers because using unvalidated operating systems may lead to incorrect patient treatment.
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 risk of incorrect radiation treatment, which constitutes a significant injury risk.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 87 units of the LANTIS Oncology Information System Servers. These servers are used by radiation therapists to deliver treatment to patients using the MEVATRON system and its accessories. The affected units include models 04503178, 05493072, and 08148178 with specific serial numbers listed in the recall notice.
The recall is due to a potential safety risk when the LANTIS server software is used with operating systems that have not been validated or released for the system. This incompatibility can lead to an incorrect treatment being delivered to the patient. The products were distributed nationwide.
Healthcare facilities and users of these servers should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the issue. The source text does not specify a particular action for consumers, as these are medical devices used in professional settings.
The recalled product
- Product
- Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 87
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 (2)
- Models: 04503178
- 05493072
Distribution
Distributed nationwide across the United States.
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