FDA-Device2013-10-30Class II
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.
Philips Medical Systems (Cleveland) Inc
Hazard
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.
Sold states
Worldwide Distribution - US (nationwide) including FL, CO, KY, MS, PA, NC, NJ, TX and Puerto Rico and internationally to Italy.
Affected count
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)
Manufactured in
595 Miner Rd, N/A, Cleveland, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0033-2014Don't want to check this manually?
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