Siemens SOMATOM CT Systems Recalled for Loose Light Marker Windows
Siemens is recalling 762 SOMATOM CT systems because loose light marker windows could allow access to rotating or electrical parts.
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 electrical shock or mechanical injury from rotating parts, which is 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 762 SOMATOM Definition AS and Definition Flash computed tomography (CT) systems distributed in the United States. The recall addresses a defect in the small light marker windows integrated into the front cover of the systems, which are used for the positioning laser.
The light marker windows may become loose or potentially drop out. If a window drops out, there is a risk that a person could reach through the opening and touch rotating or electrical parts of the gantry.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the issue. The source text does not specify a date for the recall or report any injuries.
The recalled product
- Product
- SOMATOM Definition AS, Computed tomography system Product Usage: SOMATOM Definition Flash systems are 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…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 762
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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