Hitachi Medical Systems America Inc Hitachi Scenaria Whole-body X-ray CT System Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Hitachi Scenaria Whole-body X-ray CT System
Brand
Hitachi Medical Systems America Inc
Lot Codes / Batch Numbers
Scenaria units S5002-S5014, S5017-S5044
Products Sold
Scenaria units S5002-S5014, S5017-S5044
Hitachi Medical Systems America Inc is recalling Hitachi Scenaria Whole-body X-ray CT System due to There is a possibility that the cables to the controller unit may not be affixed properly, creating the potential for a cable to detach during scannin. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a possibility that the cables to the controller unit may not be affixed properly, creating the potential for a cable to detach during scanning and eject from the system.
Recommended Action
Per FDA guidance
An Urgent Medical Device Correction Notice dated 10/15/19 was sent to customers. Hitachi will inspect all heat controller units for Scenaria systems S5002-S5014 and S5017-S5044 to ensure that the cables and cable loop clamp are affixed as instructed and apply modifications as needed. We expect to begin this process in late October I early November 2019. This action will be implemented by Hitachi Service at no charge to you. Your Service Area Manager will contact you for scheduling. Please contact me if you need further information regarding this report. You can send any questions, comments or requests to recalls@hitachihealthcare.com.
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 noticeDistribution
As reported by FDA
CA, FL, GA, IN, IA, MD, MT, NY, NC, OH, OK, SD, TN, TX, WY, PR
Page updated: Jan 10, 2026