Recall Z-0271-2020— Hitachi Medical Systems America Inc
Class II · Terminated
Class II FDA medical device recall by Hitachi Medical Systems America Inc, initiated 2019-10-16, terminated 2020-04-30. It names 2 FDA 510(k) clearances: K150595, K101888. Product: Hitachi Scenaria Whole-body X-ray CT System. Reason: 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..
- Recalling firm
- Hitachi Medical Systems America Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-10-16
- Terminated
- 2020-04-30
- Firm location
- Twinsburg, OH, United States
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Hitachi Scenaria Whole-body X-ray CT System
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.