No image published for this recall

No image published for this recall

Cara v4

Official notice

24 Jan 2022

Last checked

24 Jan 2022

Medium riskHealth Canada

An official Health Canada notice concerns Cara v4. Potential violation of the rules and regulations related to market approval of some features of the software medical device Cara based on artificial intelligence. Recall start date: Jan 11, 2022 Published 2022-01-24.

What to do now

Contact the manufacturer if you require additional information.

Recall number

63861

Official notice

2022-01-24

The hazard

Potential violation of the rules and regulations related to market approval of some features of the software medical device Cara based on artificial intelligence. Recall start date: Jan 11, 2022

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

63861

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Affected products

Product 1

Affected Products - Cara V4, Lot or serial number - All lots., Model or catalog number - CARA V4

Risk / hazard

Potential violation of the rules and regulations related to market approval of some features of the software medical device Cara based on artificial intelligence. Recall start date: Jan 11, 2022

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: Diagnos, Cara V4.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

63861

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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