Z-0515-2013Class II

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

Name: Z-0515-2013 MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system Ceiling mounted surgical light
Creator: Siemens Medical Solutions USA, Inc
Published: 2012-10-10
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2012-10-10 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system Ceiling mounted surgical light on 2012-10-10. FDA classified it as Class II and gives the reason as "A particular component may not have been fitted during the installation of some MAVIG PORTEGRA 2 systems". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0515-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-10
Posted: 2012-12-12
Terminated: 2014-11-06
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system Ceiling mounted surgical light
Product code: FSY Light, Surgical, Ceiling Mounted
Reason for recall: A particular component may not have been fitted during the installation of some MAVIG PORTEGRA 2 systems.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Siemens sent a Customer Safety Advisory Notice on October 3, 2012, to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were reminded that they should contact the service department in the event of damage or other irregularity. Customers were instructed to forward the information contained in the notice to their employees responsible for the operation of the affected product. Customers were also asked to forward the safety information to other organization affected by the product and to any users of the product. For questions regarding this recall call 610-219-4834.
Quantity in commerce: 1315
Distribution: Nationwide Distribution
Product codes and lots: Part numbers 7721165, 4787714, 7559375, 10281150, 10281151, 10281152 and 10281183

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0515-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0515-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-12

Product code FSY

K063333Class IIM3Mavig GmbH / cleared 2006-11-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)