Hitachi Medical Systems America Inc Hitachi Altaire Magnetic Resonance Imaging System Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Hitachi Altaire Magnetic Resonance Imaging System
Brand
Hitachi Medical Systems America Inc
Lot Codes / Batch Numbers
L001 thru L223.
Products Sold
L001 thru L223.
Hitachi Medical Systems America Inc is recalling Hitachi Altaire Magnetic Resonance Imaging System due to 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 cir. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026