Recall Z-0786-2014— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0786-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-11

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2013-12-11, terminated 2014-03-31. It names one FDA 510(k) clearance: K953233. Product: SIMVIEW NT and SIMVIEW NT with IDI: October 01, 2012 Siemens ceased Simview distribution. Manufactured by: Mecaserto now known as Mecasim Parc de lEsplanade 9,Rue Niels Bohr 77400 Saint Thibault des Vignes- France The intended use of the SIEMENS branded SIMVIEW NT and SIMVIEW NT with IDI is a radiation therapy simulation system.. Reason: In a very rare occurrence an intended movement of the SimView NT simulation system components could not be stopped with usual hand control or the collision detection functionality..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2013-12-11
Terminated: 2014-03-31
Firm location: Martinez, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K953233 — SIMVIEW 3000 CT OPTIONSiemens Medical Solutions USA, Inc.·cleared 1996-11-29

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

SIMVIEW NT and SIMVIEW NT with IDI: October 01, 2012 Siemens ceased Simview distribution. Manufactured by: Mecaserto now known as Mecasim Parc de lEsplanade 9,Rue Niels Bohr 77400 Saint Thibault des Vignes- France The intended use of the SIEMENS branded SIMVIEW NT and SIMVIEW NT with IDI is a radiation therapy simulation system.

Reason for recall

In a very rare occurrence an intended movement of the SimView NT simulation system components could not be stopped with usual hand control or the collision detection functionality.

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