FDA-Device2021-08-25Class II
Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures
Hitachi Healthcare Americas Corporation
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.
Sold states
Worldwide distribution - US Nationwide and the country of Canada.
Affected count
120 units
Manufactured in
1959 Summit Commerce Park, N/A, Twinsburg, OH, United States
Products
Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2308-2021Don't want to check this manually?
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