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Infinity® central station

Official notice

22 Mar 2023

Last checked

22 Mar 2023

High riskHealth Canada

An official Health Canada notice concerns Infinity® central station. During our global market surveillance activities, we have become aware of cases in which the software on the Infinity® Central Station drops peaks on narrow waveforms causing the Infinity® M300 to fail the requirements of the standard IEC 60601-2-27. Recall start date: March 9, 2023 Published 2023-03-22.

What to do now

Contact the manufacturer if you require additional information.

Recall number

73365

Official notice

2023-03-22

The hazard

During our global market surveillance activities, we have become aware of cases in which the software on the Infinity® Central Station drops peaks on narrow waveforms causing the Infinity® M300 to fail the requirements of the standard IEC 60601-2-27. Recall start date: March 9, 2023

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

73365

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Affected products

Product 1

Affected products - Infinity® Centralstation Wide, Lot or serial number - All lots., Model or catalog number - MS26800

Product 2

Affected products - Infinity® Central Station, Lot or serial number - All lots., Model or catalog number - MS 18500 MS26800

Product 3

Affected products - Infinity® M300+, Lot or serial number - All lots., Model or catalog number - MS33648 MS33659 MS33950

Product 4

Affected products - Infinity® M300, Lot or serial number - All lots., Model or catalog number - MS 25755 MS18501 MS 26076

Risk / hazard

During our global market surveillance activities, we have become aware of cases in which the software on the Infinity® Central Station drops peaks on narrow waveforms causing the Infinity® M300 to fail the requirements of the standard IEC 60601-2-27. Recall start date: March 9, 2023

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: Draeger Medical, Infinity® Central Station.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type I

App estimate

high

Recall details

Recall number

73365

Classification

Type I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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