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U.S. Department of Health and Human Services

Class 2 Device Recall MAVIG PORTEGRA 2 system

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 Class 2 Recall
MAVIG PORTEGRA 2 system
see related information
Date Posted December 12, 2012
Recall Status1 Terminated on November 06, 2014
Recall Number Z-0515-2013
Recall Event ID 63496
Premarket Notification
510(K) Number
K063333 
Product Classification Light, Surgical, Ceiling Mounted - Product Code FSY
Product MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system Ceiling mounted surgical light
Code Information Part numbers 7721165, 4787714, 7559375, 10281150, 10281151, 10281152 and 10281183
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
For Additional Information Contact Customer Support
610-219-6300
Manufacturer Reason
for Recall
A particular component may not have been fitted during the installation of some MAVIG PORTEGRA 2 systems.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FSY and Original Applicant = MAVIG GMBH
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