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St80i stress test system

Official notice

31 Jan 2022

Last checked

31 Jan 2022

Medium riskHealth Canada

An official Health Canada notice concerns St80i stress test system. When patient demographic information is entered into the system and the patient information is saved or exported to a folder, in very rare situations, the demographic information that is displayed is that of the previous patient instead of the current patient resulting in patient data mismatch. There have been complaints related to this issue, but to date there have been no reports of patient injury. Recall start date: Dec 20, 2021 Published 2022-01-31.

What to do now

Contact the manufacturer if you require additional information.

Recall number

63874

Official notice

2022-01-31

The hazard

When patient demographic information is entered into the system and the patient information is saved or exported to a folder, in very rare situations, the demographic information that is displayed is that of the previous patient instead of the current patient resulting in patient data mismatch. There have been complaints related to this issue, but to date there have been no reports of patient injury. Recall start date: Dec 20, 2021

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

63874

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Affected products

Product 1

Affected Products - St80i Stress Test System, Lot or Serial Number - More than 10 numbers, contact manufacturer., Model or catalog number - 860343

Risk / hazard

When patient demographic information is entered into the system and the patient information is saved or exported to a folder, in very rare situations, the demographic information that is displayed is that of the previous patient instead of the current patient resulting in patient data mismatch. There have been complaints related to this issue, but to date there have been no reports of patient injury. Recall start date: Dec 20, 2021

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: Philips, St80i Stress Test System.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

63874

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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