Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 의 리콜

Recall

66312

Class 2

Z-0033-2014

2013-08-07

2013-10-21

Terminated

United States

2014-03-26

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122031

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.