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Hitachi Healthcare Americas Corporation recalls Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and
Recalled August 25, 2021 · FDA recall Z-2308-2021 · Hitachi Healthcare Americas
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. · FDA Class II
Units
120 units
Sold at
Worldwide distribution - US Nationwide and the country of Canada.
Description
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.
Product
Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures
Manufacturer(s)
Hitachi Healthcare Americas Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →