Recall Z-1598-2016— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1598-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-13

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2016-04-13, terminated 2017-04-17. It names one FDA 510(k) clearance: K101347. Product: MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915. Docking station top cover (part no# 10591430) of the removable patient table.. Reason: The docking station top cover of the removable patient table may contain a magnetic metal plate. When docking/undocking the table, the magnetic top cover may become attracted to the magnet..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-04-13
Terminated: 2017-04-17
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K101347 — MAGNETOM AERA; MAGNETOM SKYRASiemens Medical Solutions USA, Inc.·cleared 2010-10-01

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

MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915. Docking station top cover (part no# 10591430) of the removable patient table.

Reason for recall

The docking station top cover of the removable patient table may contain a magnetic metal plate. When docking/undocking the table, the magnetic top cover may become attracted to the magnet.

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