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U.S. Department of Health and Human Services

Class 3 Device Recall Infinion 1.5 T MRI Scanner.

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  Class 3 Device Recall Infinion 1.5 T MRI Scanner. see related information
Date Initiated by Firm April 17, 2003
Date Posted December 02, 2004
Recall Status1 Terminated 3 on October 29, 2008
Recall Number Z-0272-05
Recall Event ID 30416
510(K)Number K003853  K011296  software:K024066  
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product Intinion 1.5 T MRI Scanner.
Code Information Serial Numbers ZA101-ZA188, ZA190-192, ZA195, ZA200, ZA201.
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland OH 44143-2131
For Additional Information Contact Michael J. Hayes
440-483-3521
Manufacturer Reason
for Recall		 There is a potential for the patient to be exposed to cryogenic fluids (liquid air) dripping from the vent during a quench due to the location of the vent.
FDA Determined
Cause 2		 Other
Action A Mandatory Service Letter, dated April 17, 2003, was sent to service technicians instructing the technicans to perform a mandatory safety modification.
Quantity in Commerce 93 units.
Distribution Throughout the United States and to Denmark, England, China, Italy, Mexico, Israel, and Puerto Rico.
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 = LNH and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
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