Hitachi Healthcare Americas

4 recalls •

• Categories: Other Medical Devices, Diagnostic Equipment

OASIS MRI System

Class I - Dangerous

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.

Jul 29, 2021 Other Medical Devices Nationwide View Details →

ECHELON MRI System

Class I - Dangerous

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.

Jul 29, 2021 Other Medical Devices Nationwide View Details →

ECHELON Oval MRI System

Class I - Dangerous

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.

Jul 29, 2021 Other Medical Devices Nationwide View Details →

Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures

Class I - Dangerous

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.

Jun 30, 2021 Diagnostic Equipment Nationwide View Details →