Siemens Symbia T Series Imaging Systems Recalled for Overheating Risk
Siemens Medical Solutions is recalling Symbia T Series imaging systems because improper fuses could cause the Power Controller assembly to overheat.
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 (overheating electrical component) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the Siemens Symbia T Series radiological imaging systems. These systems combine a single photon emission computed tomography (SPECT) camera for nuclear medicine images and a computed tomography (CT) camera for x-ray images. The recall involves 1,700 units distributed worldwide, including the United States, Puerto Rico, and numerous international locations.
The recall is due to fuses with improper amperage ratings installed in the Symbia S, Symbia T Series, and Symbia Intevo systems. According to the source, these fuses, in conjunction with a specific failure mode of the Power Controller assembly, could lead to the overheating of the assembly. The affected model numbers are 8717733, 10275007, 10275008, 10275009, and 10275010.
The source text does not specify specific actions for consumers or healthcare facilities, nor does it report any injuries or illnesses associated with this defect.
The recalled product
- Product
- Siemens Symbia T Series, a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images.
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Hazard
- Affected units
- 1,700
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 (4)
- Model numbers: 8717733
- 10275007
- 10275008
- 10275009 and 10275010.
Distribution
Part of a larger recall action
This product is one of 3 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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