Twinsburg, OH, United States
Hitachi Healthcare Americas Corporation recalls
2 recalls recorded since 2018, most recently on 29 July 2021. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 29 July 2021
- Terminated
- 8 September 2023
- Reason
- There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of Federal Regulations section 21CFR801.437.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Mexico and Brazil.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2339-2021, Z-2337-2021, Z-2338-2021
- OASIS MRI System
- ECHELON MRI System
- ECHELON Oval MRI System
Ongoing Class II Medical devices
- Recall started
- 30 June 2021
- Reason
- The screw cover at the tip of the probe may fall off after a cleaning and sterilization process. Users advised to conduct a preventive inspection of the probe before and after sterilization/disinfection/cleaning and before and after an interoperative procedure.
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2308-2021
- Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.