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2Nd generation centrimag™ primary console with em-tec adult flow probe

Official notice

14 Jun 2024

Last checked

14 Jun 2024

Medium riskHealth Canada
Watch Abbott Medical

An official Health Canada notice concerns 2Nd generation centrimag™ primary console with em-tec adult flow probe. Abbott is notifying users of a potential issue identified through our internal process with the CentriMag™ console (2nd generation CentriMag™ primary console) which is a part of the CentriMag™ Circulatory Support System. Internal testing showed that due to a component change, the CentriMag™ console may not conform to the IEC 61000-4-5 standard. If subjected to a power surge above 1.8kV and up to 2.0 kV, the CentriMag™ console may shut down completely without alarm. A power surge may be caused by, including, but not limited to the following: lightning strike, unregulated power switching, or faulty equipment. Pumping would cease and the patient would have to be switched to a backup. Recall start date: May 22, 2024 Published 2024-06-14.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75670

Official notice

2024-06-14

The hazard

Abbott is notifying users of a potential issue identified through our internal process with the CentriMag™ console (2nd generation CentriMag™ primary console) which is a part of the CentriMag™ Circulatory Support System. Internal testing showed that due to a component change, the CentriMag™ console may not conform to the IEC 61000-4-5 standard. If subjected to a power surge above 1.8kV and up to 2.0 kV, the CentriMag™ console may shut down completely without alarm. A power surge may be caused by, including, but not limited to the following: lightning strike, unregulated power switching, or faulty equipment. Pumping would cease and the patient would have to be switched to a backup. Recall start date: May 22, 2024

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

75670

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Affected products

Product 1

Affected products - 2nd Generation CentriMag™ Primary Console With Em-Tec Adult Flow Probe, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 201-90421

Risk / hazard

Abbott is notifying users of a potential issue identified through our internal process with the CentriMag™ console (2nd generation CentriMag™ primary console) which is a part of the CentriMag™ Circulatory Support System. Internal testing showed that due to a component change, the CentriMag™ console may not conform to the IEC 61000-4-5 standard. If subjected to a power surge above 1.8kV and up to 2.0 kV, the CentriMag™ console may shut down completely without alarm. A power surge may be caused by, including, but not limited to the following: lightning strike, unregulated power switching, or faulty equipment. Pumping would cease and the patient would have to be switched to a backup. Recall start date: May 22, 2024

Where it was sold

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

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Abbott Medical, 2nd Generation Centrimag™ Primary Console With Em-tec Adult Flow Probe

Manufacturer

Not provided

Phone

Not provided

Brand: Abbott Medical, 2nd Generation Centrimag™ Primary Console With Em-tec Adult Flow Probe.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

75670

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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