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Terminated

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

FDA Recall Z-0515-2013 · Posted 2012-12-12

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeFSY
Date Initiated2012-10-10
Date Terminated2014-11-06
Product Quantity1315

Reason for Recall

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

Firm 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.

Root Cause

Equipment maintenance

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K063333M3Mavig GmbH · 2006-11-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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