Siemens Symbia T Series Medical Imaging Systems Recalled for Rubber Isolator Defect
Siemens is recalling 1,039 Symbia T Series SPECT/CT systems because a rubber isolator may degrade, potentially leading to drive belt rupture.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text explicitly states that the event does not pose a hazard by itself, indicating a theoretical risk of mechanical failure without reported injuries.
Plain-English summary
Siemens Medical Solutions USA, Inc. is performing a field correction for 1,039 Symbia T Series medical imaging systems, including the T16, T6, T2, and T models. These systems are used for SPECT and CT diagnostic applications in oncology, neurology, and cardiology.
The recall is due to a rubber isolator within the rotate motor mounting assembly that has unfavorable aging properties. The function of this isolator may degrade over time, which could impact motor support. While the event does not pose a hazard by itself, it could lead to a rupture of the drive belt.
The affected systems were distributed worldwide, including in the United States, Puerto Rico, and numerous international locations. Siemens is conducting this field correction to address the potential mechanical failure.
The recalled product
- Product
- The Symbia T Series consists of the T16, T6, T2, and T. The Symbia T integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping. The system can also be used as a complete clinical SPECT system for general…
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Hazard
- Affected units
- 1,039
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
- Product Code: 10275007
- Serial Numbers: 1055
- 1056
- 1057
- 1058
- 1060
- 1061
- 1062
- 1063
- 1064
- 1065
- 1066
- 1067
- 1068
- 1069
- 1070
- 1071
- 1072
- 1073
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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