Recall Z-0919-2017— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0919-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-22

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2016-11-22, terminated 2017-05-30. It names one FDA 510(k) clearance: K151749. Product: SOMATOM Scope, Computed tomography x-ray system. Reason: Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Connection Box (LCB) to resolve a potential defect that could lead to a power cutout during use of the SOMATOM Scope, Scope Power and Perspective systems..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-11-22
Terminated: 2017-05-30
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K151749 — somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version)Siemens Medical Solutions USA, Inc.·cleared 2016-03-18

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 Scope, Computed tomography x-ray system

Reason for recall

Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Connection Box (LCB) to resolve a potential defect that could lead to a power cutout during use of the SOMATOM Scope, Scope Power and Perspective systems.

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