Recall Z-1770-2017— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1770-2017
Creator: U.S. Food and Drug Administration
Published: 2016-10-17

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2016-10-17, terminated 2017-10-24. It names one FDA 510(k) clearance: K101347. Product: Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems. Reason: Due to a potential manufacturing error, a rare possibility exists for a sudden drop in table height of the Combi Dockable Table Neurosurgery..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-10-17
Terminated: 2017-10-24
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

Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems

Reason for recall

Due to a potential manufacturing error, a rare possibility exists for a sudden drop in table height of the Combi Dockable Table Neurosurgery.

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