Single Use Distal Cover
Brand(s)
Last updated
Summary
Product
Single Use Distal Cover
Issue
Medical devices - Performance issue
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
0 |
Affected product |
Lot or serial number |
Model or catalogue number |
|---|---|---|---|
1 |
Single Use Distal Cover |
More than 10 numbers, contact manufacturer. |
MAJ-2315 |
Issue
Olympus has become aware that the single use distal cover MAJ-2315 may cause mucosal injury, become cracked and/or detach from the endoscope during use. Olympus redesigned the distal cover and has observed a decrease in the referenced complaints. Olympus is initiating a medical device recall for distal covers with the original design.
Recall start date: April 21, 2023
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Orthopaedics
Companies
Olympus Medical Systems Corp.
2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-73600
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