Health product recall

Ultrasonic Gastrovideoscope

Last updated

Summary

Product
Ultrasonic Gastrovideoscope
Issue
Medical devices - Unauthorised device
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or Serial Number

Model or catalog number

Ultrasonic Gastrovideoscope

More than 10 numbers, contact manufacturer.

GF-UC140P-AL5

Issue

Olympus Medical Systems Corp (OMSC) conducted a postmarket risk assessment of the GFUC140P-AL5. As part of that review, OMSC applied updated FDA guidance for reprocessing validation. OMSC's testing showed that the GF-UC140P-AL5, when reprocessed in the OERPRO, would not meet the current FDA guidance for reprocessing validation without further design changes. An ineffectively reprocessed endoscope can present an infection control risk to patients. As a result, OMSC is revising the OER-PRO labelling such that the GF-UC140PAL5 is no longer a compatible endoscope for reprocessing in the OER-PRO. Olympus has not received any reported complaints of infection associated with the GFUC140P-AL5 when reprocessed in the OER-PRO.

Recall start date: Mar 18, 2022

Additional information

Details
Original published date: 2022-04-07
Alert / recall type
Health product recall
Category
Health product - Medical device - Gastroenterology & Urology
Companies

Olympus Medical Systems Corp.

2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To

Japan, 192-8507

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-64039