Siemens Symbia S Camera Systems Recalled for Bearing Failure Risk
Siemens Medical Solutions is recalling Symbia S camera systems because linear bearing cars may fail, allowing ball bearings to fall out.
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 is classified as FDA Class II. The hazard involves a mechanical failure (falling ball bearings) which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 732 units of the Symbia S camera system. The recall is due to a potential mechanical defect in the linear bearing cars that support and move the detectors horizontally and vertically.
The defect involves the potential for the linear bearing car to fail, which could allow the ball bearings to fall out. This issue affects the Symbia S and Symbia T camera systems.
The affected units were distributed worldwide, including in the United States (nationwide, Washington D.C., and Puerto Rico) and numerous international countries. Siemens Medical Solutions USA, Inc. is the recalling firm. Consumers and healthcare facilities should contact the manufacturer for instructions on how to address this defect.
The recalled product
- Product
- Symbia S, Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. 2) CT: The CT component is intended…
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Affected units
- 732
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 (20)
- Material Number 8717741
- Serial Numbers: 1001
- 1002
- 1003
- 1005
- 1006
- 1007
- 1008
- 1009
- 1010
- 1011
- 1012
- 1013
- 1014
- 1015
- 1016
- 1017
- 1018
- 1019
- 1020
Distribution
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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