FDAJune 30, 2021device
Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
hitachi healthcare americashitachihitachi healthcare
Recall history
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