Recall Z-1350-2016— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1350-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-22

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2016-03-22, terminated 2017-08-07. It names one FDA 510(k) clearance: K143400. 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.. Reason: Siemens became aware that the front cover on some Siemens CT system was not properly welded. It is possible for the welded-in threaded bolt to break out of the ground plate of the front cover if the cover is opened during service. This could not happen during clinical operation. Therefore, there is no potential risk for the user or patient and the CT System has no risk for a malfunction during clinical operation.

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-03-22
Terminated: 2017-08-07
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K143400 — SOMATOM Definition AS/AS+Siemens Medical Solutions USA, Inc.·cleared 2015-04-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Siemens became aware that the front cover on some Siemens CT system was not properly welded. It is possible for the welded-in threaded bolt to break out of the ground plate of the front cover if the cover is opened during service. This could not happen during clinical operation. Therefore, there is no potential risk for the user or patient and the CT System has no risk for a malfunction during clinical operation

Data sourced from openFDA. This site is unofficial and independent of the FDA.