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Hitachi Healthcare Americas Recalls
4 recalls on record · August 25, 2021 to September 1, 2021 · Medical Devices
September 1, 2021Medical DevicesFDA
Hitachi Healthcare Americas Corporation recalls OASIS MRI System
Hazard: 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.
September 1, 2021Medical DevicesFDA
Hitachi Healthcare Americas Corporation recalls ECHELON Oval MRI System
Hazard: 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.
September 1, 2021Medical DevicesFDA
Hitachi Healthcare Americas Corporation recalls ECHELON MRI System
Hazard: 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.
August 25, 2021Medical DevicesFDA
Hitachi Healthcare Americas Corporation recalls Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and
Hazard: 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.