Recall Z-2473-2018— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-2473-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-01

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2018-02-01, terminated 2020-05-01. It names one FDA 510(k) clearance: K023687. Product: SOMATOM Emotion 16 (10165977). Reason: A potential risk of unnecessary radiation exposure due to a software issue.

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2018-02-01
Terminated: 2020-05-01
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K023687 — SOMATOM EMOTION 6 CT SYSTEMSSiemens Medical Systems, Inc.·cleared 2002-11-22

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 Emotion 16 (10165977)

Reason for recall

A potential risk of unnecessary radiation exposure due to a software issue

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