Siemens CT Systems Recalled for Potential Malfunction Hazard
Siemens is recalling 124 CT systems due to a potential malfunction hazard when using specific cardio licenses.
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 where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 124 units of SOMATOM Emotion and SOMATOM Sensation families of CT systems. These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.
The recall is initiated due to a potential malfunction that creates a potential hazard to patients and personnel when the systems are used in conjunction with the cardio licenses "Cardio Pro" and "Cardio Retro".
The affected units were distributed nationwide in the US, including Guam and specific states. The source text does not specify the actions consumers or healthcare providers should take.
The recalled product
- Product
- Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — CT Systems
- Hazard
- Affected units
- 124
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)
- Model Number: SOMATOM Emotion 16 - 7734713
Distribution
Part of a larger recall action
This product is one of 8 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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