Siemens SOMATOM Spirit CT Scanner Recalled for Software Radiation Risk
Siemens Medical Solutions is recalling SOMATOM Spirit CT scanners due to a software issue that may cause unnecessary radiation exposure.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (unnecessary radiation exposure) where the source text describes a 'potential risk' without reporting specific injuries or illnesses, fitting the High severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the SOMATOM Spirit (Model 10045692) CT scanner. The recall is being conducted because of a software issue that creates a potential risk of unnecessary radiation exposure to patients.
The affected units are identified by the following serial numbers: 31621, 31245, 79670, 31092, 31313, and 31611. The product was distributed nationwide.
Healthcare facilities and consumers should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the software issue and ensure patient safety.
The recalled product
- Product
- SOMATOM Spirit(Model 10045692 )
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — CT Scanner
- Hazard
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 (1)
- Serial No. 31621 31245 79670 31092 31313 31611
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 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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