The Recall Desk
LowFDA (Devices)·Z-1350-2016·Announced 2016-04-20

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.

What this means for you

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.
Affected units
1

Distribution

Distribution scope not specified by the agency.

Same manufacturer · Siemens Medical Solutions USA, Inc

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