ClearanceBrief
Recall Z-0272-05 ยท LNH System, Nuclear Magnetic Resonance Imaging

Philips Medical Systems (Cleveland) Inc

Intinion 1.5 T MRI Scanner.

DateDec 2, 2004 (initiated Apr 17, 2003)
StatusTerminated
ReasonThere is a potential for the patient to be exposed to cryogenic fluids (liquid air) dripping from the vent during a quench due to the location of the vent.
Root causeOther
ActionA Mandatory Service Letter, dated April 17, 2003, was sent to service technicians instructing the technicans to perform a mandatory safety modification.
Quantity93 units.
DistributionThroughout the United States and to Denmark, England, China, Italy, Mexico, Israel, and Puerto Rico.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K003853INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100
Philips Medical Systems (Cleveland), Inc., Feb 13, 2001
K011296INFINION ENHANCEMENT PACKAGE
Philips Medical Systems (Cleveland), Inc., Jul 19, 2001