Hitachi Medical Systems America Inc Hitachi AIRIS II Magnetic Resonance Imaging Device Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Hitachi AIRIS II Magnetic Resonance Imaging Device
Brand
Hitachi Medical Systems America Inc
Lot Codes / Batch Numbers
C002 thru C795, C907, and C910.
Products Sold
C002 thru C795, C907, and C910.
Hitachi Medical Systems America Inc is recalling Hitachi AIRIS II Magnetic Resonance Imaging Device due to Image reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Image reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder.
Recommended Action
Per FDA guidance
The recalling firm is sending recall letters to all consignees.
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