Recall Z-0515-2013— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0515-2013
Creator: U.S. Food and Drug Administration
Published: 2012-10-10

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2012-10-10, terminated 2014-11-06. It names one FDA 510(k) clearance: K063333. Product: MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system Ceiling mounted surgical light. Reason: A particular component may not have been fitted during the installation of some MAVIG PORTEGRA 2 systems..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2012-10-10
Terminated: 2014-11-06
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K063333 — M3Mavig GmbH·cleared 2006-11-21

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

MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system Ceiling mounted surgical light

Reason for recall

A particular component may not have been fitted during the installation of some MAVIG PORTEGRA 2 systems.

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