Recall Z-2405-2019— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-2405-2019
Creator: U.S. Food and Drug Administration
Published: 2019-07-31

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2019-07-31, terminated 2020-12-02. It names one FDA 510(k) clearance: K173632. Product: SOMATOM go.Top; Models #11061648 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. Reason: The injector holder could potentially fall off together with the injector and the storage box..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2019-07-31
Terminated: 2020-12-02
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K173632 — SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GOSiemens Medical Solutions USA, Inc.·cleared 2018-04-13

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 go.Top; Models #11061648 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data

Reason for recall

The injector holder could potentially fall off together with the injector and the storage box.

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