Hitachi Healthcare Americas Corporation FDA Recalls

4 recalls on file across devices, 0 of them Class I and 1 still open. Matched by name to HTHIY.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
ECHELON Oval MRI SystemClass IIJul 29, 2021There was no label on the pad packaging or notification in t	There was no label on the pad packaging or notification in the user manual that the table pads contained dry	Class IIDevices	Jul 29, 2021
OASIS MRI SystemClass IIJul 29, 2021There was no label on the pad packaging or notification in t	There was no label on the pad packaging or notification in the user manual that the table pads contained dry	Class IIDevices	Jul 29, 2021
ECHELON MRI SystemClass IIJul 29, 2021There was no label on the pad packaging or notification in t	There was no label on the pad packaging or notification in the user manual that the table pads contained dry	Class IIDevices	Jul 29, 2021
Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative andClass IIJun 30, 2021The screw cover at the tip of the probe may fall off after a	The screw cover at the tip of the probe may fall off after a cleaning and sterilization process. Users advised	Class IIDevices	Jun 30, 2021