Siemens Symbia S Series Medical Imaging Systems Recalled for Bearing Failure
Siemens Medical Solutions is recalling 719 Symbia S series 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 does not report specific injuries or fatalities, 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 719 units of the Siemens Symbia S series medical imaging systems. These systems are intended to aid in detecting, localizing, diagnosing, staging, and restaging of lesions, tumors, disease, and organ function, as well as for radiotherapy treatment planning and interventional radiology procedures.
The recall is due to a potential failure of the linear bearing car, which could allow ball bearings to fall out. The affected systems were distributed worldwide, including in the United States (nationwide, including DC and Puerto Rico) and numerous other countries.
Siemens Medical Solutions USA, Inc. is the recalling firm. The source text does not specify the corrective action or instructions for consumers or healthcare providers.
The recalled product
- Product
- The Siemens Symbia S 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
- 719
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 S
- Materal Number: 8717741
- Serial Numbers: 1001
- 1002
- 1003
- 1005
- 1006
- 1007
- 1008
- 1009
- 1010
- 1011
- 1012
- 1013
- 1014
- 1015
- 1016
- 1017
- 1018
- 1019
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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