Siemens Symbia T Series Medical Imaging Systems Recalled for Bearing Failure
Siemens Medical Solutions is recalling Symbia T series imaging systems because a linear bearing car 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 involves a mechanical defect in a medical device that poses a risk of harm (falling bearings) but the source text does not report any injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the Siemens Symbia T series medical imaging systems. These systems are intended to aid in detecting, localizing, diagnosing, staging, and restaging of lesions, tumors, disease, and organ function. The images produced by the system can also be used by physicians to aid in radiotherapy treatment planning and interventional radiology procedures.
The recall is due to a potential for the linear bearing car to fail, which would allow the ball bearings to fall out. The source text does not report any injuries, illnesses, or deaths associated with this defect.
Approximately 1,075 systems are affected globally. The distribution includes the United States (nationwide, including DC and Puerto Rico) and numerous international countries. The source text does not provide specific instructions for consumers or healthcare providers on how to address the defect.
The recalled product
- Product
- The Siemens Symbia T series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders. The images produced by the system can also be used by the physician to aid in…
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Category
- Medical Device — Imaging Systems
- Affected units
- 1,075
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)
- 1) Symbia T
- Material Number: 10275007
- Serial Numbers: 1001
- 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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