Siemens Recalls One CT System Due to Front Cover Welding Defect
Siemens is recalling one SOMATOM Definition AS CT system because a front cover weld defect could cause a bolt to break during service, though no clinical risk exists.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The source text explicitly states there is no potential risk for the user or patient and no risk of malfunction during clinical operation, fitting the criteria for cosmetic or documentation issues with no health consequence.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling one SOMATOM Definition AS CT system. The recall was initiated because the front cover on the device was not properly welded. This defect could cause a welded-in threaded bolt to break out of the ground plate if the cover is opened during service.
The source text explicitly states that this issue could not happen during clinical operation. Consequently, there is no potential risk for the user or patient, and the CT system has no risk for a malfunction during clinical operation.
The affected unit was distributed to Cincinnati, OH. The specific model number is SOMATOM Definition AS-8098027 and the serial number is SOMATOM Definition AS- 95766.
The recalled product
- Product
- SOMATOM Definition AS, a family of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission dta from either the same axial plane taken at different angles or spiral planes taken at different angles.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — CT System
- Hazard
- Affected units
- 1
Distribution
Distribution scope not specified by the agency.
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