FDA Device

Altaire, Magnetic Resonance Imaging Device.

Hazard

The absorber unit in the helium compressor which is located in equipment rooms, and is not accessed by patients or system operators, may fail under pressure, causing an explosion that damages the compressor.

What You Should Do

Remedy

The firm implemented site inspections of customers beginning on 11/19/04 which have been completed. Customers that had the suspect component had it replaced.

Products

Altaire, Magnetic Resonance Imaging Device.
Brand
Hitachi Medical Systems America Inc
UPC
Serial numbers: L001 to L191.

Units Affected

189 devices