Siemens SOMATOM Perspective CT Scanner Recalled for Software Radiation Risk
Siemens Medical Solutions is recalling SOMATOM Perspective 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 injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the SOMATOM Perspective (Model 10495568) CT scanners. The recall is due to a software issue that creates a potential risk of unnecessary radiation exposure to patients.
The affected units were distributed nationwide. The source text does not specify the number of units affected or report any illnesses or injuries resulting from the defect.
Consumers and healthcare facilities should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected. No specific consumer action is detailed in the source text beyond identifying affected units.
The recalled product
- Product
- SOMATOM Perspective (Model 10495568)
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — CT Scanner
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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