Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic Recalled by Hitachi Healthcare Americas Corporation Due to The screw cover at the tip of the...

Date: June 30, 2021
Company: Hitachi Healthcare Americas Corporation
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Hitachi Healthcare Americas Corporation directly.

Affected Products

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

Quantity: 120 units

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Hitachi Healthcare Americas Corporation

Hitachi Healthcare Americas Corporation has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report