Health product recall

2nd Generation CentriMag™ Primary Console With Em-Tec Adult Flow Probe

Brand(s)
Last updated

Summary

Product
2nd Generation CentriMag™ Primary Console With Em-Tec Adult Flow Probe
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

2nd Generation CentriMag™ Primary Console With Em-Tec Adult Flow Probe

More than 10 numbers, contact manufacturer.

201-90421

Issue

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies

Abbott Medical

6035 Stoneridge Drive, Pleasanton, California, United States, 94588

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75670

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