Recall
Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation during robotic and non-robotic intra-operative and laparoscopic procedures.
Hitachi Medical Systems America Inc · 20 Oct 2017
- Status
- Recall terminated
- Why, in the FDA's words
- “The ultrasound probe may not have adequate protection against electrical shock hazards.”
- Recall began
- 20 Oct 2017
- Company
- Hitachi Medical Systems America Inc
- Device type
- Product code (ITX)
- Concerns
- K152126
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.