Recall Z-2475-2018— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-2475-2018
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: K113287. Product: SOMATOM Perspective 16 (Model 10891666). 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

K113287 — SOMATOM PERSPECTIVESiemens Medical Solutions USA, Inc.·cleared 2012-05-23

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 Perspective 16 (Model 10891666)

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.