Hitachi Healthcare Americas Corporation recalls Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and…

Recall date

June 30, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2308-2021

FDA classification

Class II

Brand / firm

Hitachi Healthcare Americas Corporation

Sold / distributed

Worldwide distribution - US Nationwide and the country of Canada.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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