Recall Z-2308-2021 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Hitachi Healthcare Americas Corporation
Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures
| Date | Jun 30, 2021 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 120 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| FDA record | Open on fda.gov |