Siemens SOMATOM Emotion 6 CT Scanner Recall for Broken Screws
Siemens Medical Solutions is recalling 40 SOMATOM Emotion 6 CT scanners due to broken or bowed screws securing the gantry balance weight.
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 structural defect in a medical device (broken/bowed screws) where injury has not yet been reported, fitting the 'High' criteria for risk-of-harm products.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 40 units of the SOMATOM Emotion 6 CT scanner. 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 are distributed nationwide and are identified by model number 10165888 with specific serial numbers listed in the agency record.
Consumers and healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address this defect.
The recalled product
- Product
- SOMATOM Emotion 6; 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
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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