Recall Z-2308-2021— Hitachi Healthcare Americas Corporation

Name: FDA recall Z-2308-2021
Creator: U.S. Food and Drug Administration
Published: 2021-06-30

Class II · Ongoing

Class II FDA medical device recall by Hitachi Healthcare Americas Corporation, initiated 2021-06-30. It names 2 FDA 510(k) clearances: K183456, K173739. Product: Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures. 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..

Recalling firm: Hitachi Healthcare Americas Corporation
Classification: Class II
Status: Ongoing
Initiated: 2021-06-30
Firm location: Twinsburg, OH, United States

510(k) clearances named in this recall

2 on FDA's record

K183456 — Aloka Arietta 850Hitachi Healthcare Americas·cleared 2019-01-28
K173739 — ALOKA ARIETTA 850Hitachi Healthcare Americas Corporation·cleared 2018-02-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.