Siemens Symbia S Series Nuclear Medicine Imaging Systems Recalled for Overheating Risk
Siemens is recalling Symbia S Series nuclear medicine 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) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 1,183 units of the Symbia S Series diagnostic nuclear medicine imaging system. The recall involves systems installed in imaging facilities or used in mobile environments. The affected model number is 8717741.
The recall is due to fuses with the improper amperage rating being installed in the Symbia S, Symbia T Series, and Symbia Intevo systems. When these fuses are used in conjunction with a specific failure mode of the Power Controller assembly, they could lead to the overheating of the assembly.
The affected systems were distributed worldwide, including in the United States, Puerto Rico, and numerous international locations. The source text does not specify the number of reported injuries or illnesses associated with this defect.
The recalled product
- Product
- Siemens Symbia S Series system, a diagnostic analog or digital detector based planar (2- dimensional) nuclear medicine (NM) imaging system installed and used in only one location within an imaging facility or in a mobile/ transportable imaging environment.
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Hazard
- Affected units
- 1,183
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 (1)
- Model number 8717741.
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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