Philips Medical Systems (Cleveland) Inc began a recall of Intinion 1.5 T MRI Scanner on . The reason FDA records is "There 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". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0272-05
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Philips North America LLC
- Product
- Intinion 1.5 T MRI Scanner.
- Product code
- LNH System, Nuclear Magnetic Resonance Imaging
- Reason for recall
- There 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.
- FDA root cause
- Other
- Action
- A Mandatory Service Letter, dated April 17, 2003, was sent to service technicians instructing the technicans to perform a mandatory safety modification.
- Quantity in commerce
- 93 units.
- Distribution
- Throughout the United States and to Denmark, England, China, Italy, Mexico, Israel, and Puerto Rico.
- Product codes and lots
- Serial Numbers ZA101-ZA188, ZA190-192, ZA195, ZA200, ZA201.
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