Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA Orders Custom Ultrasonics To Recall All Endoscope Reprocessors

This article was originally published in The Gray Sheet

Executive Summary

The rare recall order comes as a result of a consent-decree violation by the company, which supplies endoscope reprocessors to almost 3,000 hospitals nationwide. FDA says Custom Ultrasonics has failed to validate its device designs, among other concerns.

Advertisement

Related Content

Facilities Must Stop Using Custom Ultrasonics' System To Reprocess Duodenoscopes, FDA Warns
Scope Firms, FDA Faulted In 300-Page Senate Report Seeking Device Reforms
Duodenoscope-Makers Ordered By FDA To Conduct Sec. 522 Postmarket Surveillance Studies
FDA Announces Two More Medical Device Consent Decrees

Topics

Advertisement
UsernamePublicRestriction

Register

MT034397

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

All set! This Question has been sent to my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel