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

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.

Hitachi issued Urgent Medical Device Correction Letter to customers on 6/30/2021 using FedEx (with tracking). Letter states reason for recall, health risk and action to take: Customers/Users are advised to: 1. Remember to thoroughly inspect the probe before and upon completion of your cleaning and sterilization process and before and after any interoperative procedure as indicated in the Cleaning, Disinfection and Sterilization Instruction Manual including verifying the 2 screw covers are not loose, damaged, dislodged, or missing. 2. If any abnormalities exist, immediately remove the probe from service and contact Hitachi Customer Service at 1-800-800-4925. 3. Please complete the attached Medical Device Recall Return Response Form and return to Hitachi at your earliest convenience. Type of Action by the Company: An updated manual is included with newly manufactured L43K probes to include the above diagram for additional clarification. (7) Other Information: For questions, comments, or concerns, please contact: Aaron Pierce Director, QA/RA 1959 Summit Commerce Park Twinsburg, OH 44087 Phone (330) 425-1313 x2934, Fax (330) 963-0749 Email [email protected]