Recall Z-1488-2017— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1488-2017
Creator: U.S. Food and Drug Administration
Published: 2017-02-14

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2017-02-14, terminated 2017-12-18. It names one FDA 510(k) clearance: K072485. Product: ARTISTE" MV System. Reason: Software update.

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2017-02-14
Terminated: 2017-12-18
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K072485 — ARTISTE MV SASiemens Medical Solutions USA, Inc.·cleared 2007-12-27

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

ARTISTE" MV System

Reason for recall

Software update

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