Siemens SOMATOM CT Systems Recalled for Loose Light Marker Windows
Siemens is recalling SOMATOM Definition AS and Flash CT systems because light marker windows may become loose or drop out, creating a risk of contact with rotating or electrical parts.
What this means for you
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 contact with rotating or electrical parts, which poses a potential for injury, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling SOMATOM Definition AS and SOMATOM Definition Flash computed tomography (CT) systems. The recall involves 3,077 systems worldwide, with 760 systems distributed in the United States.
The recall is due to a problem with the small light marker windows integrated into the front cover of the systems. These windows, used for the positioning laser, can become loose or potentially drop out. If a window drops out, there is a risk that a person could touch rotating or electrical parts of the gantry if they reach through the window opening.
Healthcare facilities should check their inventory for affected serial numbers and contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the issue.
The recalled product
- Product
- SOMATOM Definition Flash, Computed tomography system Product Usage: SOMATOM Definition AS 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 spi
- Manufacturer
- Siemens Medical Solutions USA, Inc
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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