Iris X80, X90, and PXL Intra-Oral Cameras
Brand(s)
Last updated
Summary
Product
Iris X80, X90, and PXL Intra-Oral Cameras
Issue
Medical devices - Unauthorised device
What to do
Affected customers will be notified.
Audience
Healthcare
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Iris X80 Intra-Oral Camera |
All lots. |
IRIS-X80 |
Iris X90 Intra-Oral Camera |
All lots. |
IRIS-X90 |
PXL Intraoral Camera |
All lots. |
PXL-1000 |
Issue
Class II medical device sold and distributed as a class I medical device. No defects or known safety related issues.
Recall Start Date: December 12, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Health products - Medical devices - General hospital and personal use
Companies
Digital-Doc
4789 Golden Foothill Parkway, El Dorado Hills, California, United States, 95762
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76776
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