—#35828

Product

Intinion 1.5 T MRI Scanner.

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K003853, K011296
Affected lot / code info: Serial Numbers ZA101-ZA188, ZA190-192, ZA195, ZA200, ZA201.

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

A Mandatory Service Letter, dated April 17, 2003, was sent to service technicians instructing the technicans to perform a mandatory safety modification.

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Road, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern: Throughout the United States and to Denmark, England, China, Italy, Mexico, Israel, and Puerto Rico.

Timeline

Recall initiated: 2003-04-17
Posted by FDA: 2004-12-02
Terminated: 2008-10-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #35828. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.