Device 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.
Z-0033-2014
Product summary
- Event
- Event 66312
- Status
- Terminated
- Classification
- Class II
- Quantity
- 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)
- Official record key
device-enforcement:Z-0033-2014
Official wording
Reason: 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.
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.
Distribution pattern: Worldwide Distribution - US (nationwide) including FL, CO, KY, MS, PA, NC, NJ, TX and Puerto Rico and internationally to Italy.
Derived failure modes
-
Unknown
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.