Hitachi Altaire Magnetic Resonance Imaging System
This recall has been terminated (originally issued June 10, 2006).
- Recall Initiated
- January 27, 2006
- Posted
- June 10, 2006
- Terminated
- November 13, 2008
- Recall Number
- Z-1103-06
- Quantity
- 213 devices have been distributed and installed.
- Firm Location
- Twinsburg, OH
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide-The device was distributed to consignees located throughout the United States.
Lot / Code Info
L001 thru L223.
Root Cause
Other
Action Taken
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.