Siemens SOMATOM Emotion 16 CT Scanners Recalled for Broken Gantry Screws
Siemens is recalling 40 SOMATOM Emotion 16 CT scanners due to broken or bowed screws in the gantry balance weight assembly.
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 describes a potential safety issue found during a service call without reporting specific injuries or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 40 units of the SOMATOM Emotion 16 CT scanner. These devices are used to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.
The recall was initiated after a potential safety issue was identified during a service call at a customer site. The issue involves two broken screws and one bowed screw used to fix the Balance Weight of the DMS in the gantry.
The affected units were distributed nationwide. Consumers and healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the recall and necessary repairs.
The recalled product
- Product
- SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — CT Scanner
- Hazard
- Affected units
- 40
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 numbers: 10165977
Distribution
Distributed nationwide across the United States.
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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