Hitachi Medical Systems America Inc MRP-7000, AIRIS Magnetic Resonance Imaging Systems Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MRP-7000, AIRIS Magnetic Resonance Imaging Systems
Brand
Hitachi Medical Systems America Inc
Lot Codes / Batch Numbers
Asset Tag Numbers: 7001-7154, A007-A901, AG004-AG039
Products Sold
Asset Tag Numbers: 7001-7154; A007-A901; AG004-AG039
Hitachi Medical Systems America Inc is recalling MRP-7000, AIRIS Magnetic Resonance Imaging Systems due to Software anomaly. A software defect in the referenced systems can cause a slice indicator (reference line) to be mis-positioned on the cross-reference. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software anomaly. A software defect in the referenced systems can cause a slice indicator (reference line) to be mis-positioned on the cross-reference image when it is magnified. This image error could result in a possible patient mis-diagnosis.
Recommended Action
Per FDA guidance
On 3/17/2006, the firm began conducting a survey of all afftected customer sites in order to determine if corrected software has been installed on the unit(s) at each customer location. If the corrected software has not been installed, the firm''s Field Service Engineers will install software upgrades as necessary.
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