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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = FSY
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