Recall Z-1939-2018— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1939-2018
Creator: U.S. Food and Drug Administration
Published: 2018-04-20

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2018-04-20, terminated 2019-05-23. It names one FDA 510(k) clearance: K163296. Product: SOMATOM go.Now, Material Number 11061618 There is a potential for a software issue that may cause the need for necessary patient rescans.. Reason: There is a potential for a software issue that may cause the need for necessary patient rescans..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2018-04-20
Terminated: 2019-05-23
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K163296 — SOMATOM go.Up, SOMATOM go.NowSiemens Medical Solutions USA, Inc.·cleared 2017-03-21

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.Now, Material Number 11061618 There is a potential for a software issue that may cause the need for necessary patient rescans.

Reason for recall

There is a potential for a software issue that may cause the need for necessary patient rescans.

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