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U.S. Department of Health and Human Services

Class 2 Device Recall Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T

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 Class 2 Recall
Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T
see related information
Date Posted October 21, 2013
Recall Status1 Terminated on March 26, 2014
Recall Number Z-0033-2014
Recall Event ID 66312
Premarket Notification
510(K) Numbers
K003853  K013858  K964626  K971884 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.
Code Information M/N: 781220, 781230, 781301, 78129 and 78127. Codes: AM128, 1510, 1518, BA318, AM120, ZA178, ZA196, ZA107, ZA133, ZA172, ZA158, BA149 and ZA208.
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland, Ohio 44143-2131
For Additional Information Contact Dominic Siewko
800-722-9377
Manufacturer Reason
for Recall
There is a potential for water to collect in the vent pipe elbow in the magnet venting system. Water may freeze, blocking the venting system.
FDA Determined
Cause 2
DESIGN: Device Design
Action Philips Healthcare sent an Urgent Medical Device Correction letter via certified mail on August 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the information with all of their staff who need to be aware of the contents of this communication. Philips Healthcare will perform any necessary corrective actions prior to the customer's next cryogen refill. Customers with questions were instructed to contact their Philips field service representative: Technical Support Line 1-800-722-9377. For questions regarding this recall call 1-800-722-9377.
Quantity in Commerce Total 511 (Asset 0.5T,: 35 units Apollo 0.5T: 15 units, Infinion 1.5T: 116 units, Eclipse/Polaris 1.5T: 290 units, Panorama 0.6T: 55 units)
Distribution Worldwide Distribution - US (nationwide) including FL, CO, KY, MS, PA, NC, NJ, TX and Puerto Rico and internationally to Italy.
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 = LNH and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
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