Device Recall Hitachi Altaire Magnetic Resonance Imaging Device 의 리콜

Recall

34856

Class 2

Z-1103-06

2006-01-27

2006-06-10

Terminated

United States

2008-11-13

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44831

Circuit failure-there is the potential risk of the phase loss detector safety device (phsen pcb) malfunctioning in the event of a power loss. the circuit may fail to turn off the system main breaker when 2 of the 3 power phases are lost.

The recalling firm sent a Device Correction Letter dated 1/27/06 to all of their customers. The letter informs the customers of the problem in the (PHSEN PCB) and notifies the customers that an HMSA Field Service Technician will be performing a PCB modification to the unit, on-site, during their next scheduled preventative maintenance visit. Should the customer wish to have the modification performed prior to the representative''s scheduled visit, the letter says that they can telephone their local Field Service Rep. and make arrangements to have the modification performed at their convenience.