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No image published for this recall

Iris x80, x90, and pxl intra-oral cameras

Official notice

30 Dec 2024

Last checked

30 Dec 2024

Medium riskHealth Canada

An official Health Canada notice concerns Iris x80, x90, and pxl intra-oral cameras. 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 Published 2024-12-30.

What to do now

Affected customers will be notified.

Recall number

76776

Official notice

2024-12-30

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

76776

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Affected products

Product 1

Affected products - Iris X80 Intra-Oral Camera, Lot or serial number - All lots., Model or catalog number - IRIS-X80

Product 2

Affected products - Iris X90 Intra-Oral Camera, Lot or serial number - All lots., Model or catalog number - IRIS-X90

Product 3

Affected products - PXL Intraoral Camera, Lot or serial number - All lots., Model or catalog number - PXL-1000

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Digital-doc, Iris X80 X90 And Pxl Intra-oral Cameras.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

76776

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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