Hitachi Medical Systems America Inc Magnetic Resonance Imaging Device Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Magnetic Resonance Imaging Device
Brand
Hitachi Medical Systems America Inc
Lot Codes / Batch Numbers
2006 and again in August, 2007, C014, C032, C063, C111, C138, C263, C347, *eight (8) AIRIS Elite Upgrades [System ID Numbers: H735, H736, H740, H743, H745, H746
Products Sold
L001-L225 - Altaire C001-C693* - AIRIS II C701-C790 - AIRIS II Upgrades H001-H091 - AIRIS Elite H701-H748* - AIRIS Elite Upgrades *The firm informed CIN-DO in their status reports for May, 2006 and again in August, 2007, that duplication was found in the number of system units originally reported to CIN-DO in early 2006. Ten (10) of the AIRIS II System units had been previously upgraded to AIRIS Elite units [System Unit Numbers: C012, C014, C032, C063, C111, C138, C263, C347, and C495] and are these numbers are reflected in the total # of AIRIS Elite System Unit Numbers listed above* **By the same token, *eight (8) AIRIS Elite Upgrades [System ID Numbers: H735, H736, H740, H743, H745, H746, H747 & H748] were reportedly installed well after the corrective action was underway (7/28/06 to 11/24/2006) and were not-subject to corrective action. As a result, the total # of affected system units/customers has been revised to reflect the number reported by the firm [1129] beginning with their May, 2006 status report and continuing through to their final communication to CIN-DO dated 8/21/2007. - clp
Hitachi Medical Systems America Inc is recalling Magnetic Resonance Imaging Device due to The device has a software anomaly which causes the operating system to 'lock up' and data to become corrupted during service procedures.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The device has a software anomaly which causes the operating system to 'lock up' and data to become corrupted during service procedures.
Recommended Action
Per FDA guidance
The recalling firm plans to notify their customers of this recall/soft ware correction during a scheduled visit to be conducted at each customer site by a Hitachi Field Service Technician. During the visit, the necessary corrective software will be installed. The visits/corrections began on: 2/21/06.
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