Siemens SOMATOM Perspective 16 CT Scanner Recalled for Software Issue
Siemens Medical Solutions USA is recalling SOMATOM Perspective 16 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 (unnecessary radiation exposure) where injury has not yet been reported, fitting the High severity criteria for risk-of-harm products.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the SOMATOM Perspective 16 (Model 10891666) CT scanners. The recall is being conducted because of a software issue that poses a potential risk of unnecessary radiation exposure to patients.
The affected units were distributed nationwide. The recall includes specific serial numbers, which are listed in the official FDA documentation. The source text does not specify the number of units affected or the exact dates of distribution.
Consumers and healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the software issue. The source text does not provide specific consumer action steps beyond the recall notification.
The recalled product
- Product
- SOMATOM Perspective 16 (Model 10891666)
- 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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