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.
Recall
- Recall Number
- Z-0033-2014
- Event Number
- 66312
- Firm
- Philips Medical Systems (Cleveland) Inc
- FEI Number
- 1525965
- Product Code
- LNH
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- August 7, 2013
- Posted
- October 21, 2013
- Terminated
- March 26, 2014
- Address
- 595 Miner Rd, Cleveland, OH, 44143-2131
Description
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.
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.
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.
Worldwide Distribution - US (nationwide) including FL, CO, KY, MS, PA, NC, NJ, TX and Puerto Rico and internationally to Italy.
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)