Recalls / —

—#114053

Product

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

FDA product code

FSY — Light, Surgical, Ceiling Mounted

Device class

Class 2

Medical specialty

General, Plastic Surgery

510(k) numbers

K063333

Affected lot / code info

Part numbers 7721165, 4787714, 7559375, 10281150, 10281151, 10281152 and 10281183

Why it was recalled

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

Root cause (FDA determination)

Equipment maintenance

Action the firm took

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.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern

Nationwide Distribution

Timeline

Recall initiated

2012-10-10

Posted by FDA

2012-12-12

Terminated

2014-11-06

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #114053. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.