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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 Device Recall MAVIG PORTEGRA 2 system see related information
Date Initiated by Firm October 10, 2012
Date Posted December 12, 2012
Recall Status1 Terminated 3 on November 06, 2014
Recall Number Z-0515-2013
Recall Event ID 63496
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 PA 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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FSY and Original Applicant = MAVIG GMBH
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