Recall
Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures
Hitachi Healthcare Americas Corporation · 30 June 2021
- Status
- Recall open, classified
- Why, in the FDA's words
- “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.”
- Recall began
- 30 June 2021
- Company
- Hitachi Healthcare Americas Corporation
- Device type
- Product code (IYN)
- Concerns
- K183456, K173739
What it means
A recall is the FDA's record that a company is correcting or removing a device because of a problem. Many are fixed with a software update or new instructions; the record does not say whether anyone was hurt. See our plain guide to FDA terms.
The record
The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.