Recall Z-1244-2019— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1244-2019
Creator: U.S. Food and Drug Administration
Published: 2019-02-14

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2019-02-14, terminated 2020-05-01. It names one FDA 510(k) clearance: K173630. Product: SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.. Reason: Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2019-02-14
Terminated: 2020-05-01
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K173630 — SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM ConfidenceSiemens Medical Solutions USA, Inc.·cleared 2018-03-30

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 Confidence, Model Number 10590100 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

Reason for recall

Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube.

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