Public recall detail

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

2024-06-14

medium
Recall Safety notice
Quick summary

Quick summary: 2nd Generation CentriMag™ Primary Console With Em-Tec Adult Flow Probe. Date: 2024-06-14.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: 2nd Generation CentriMag™ Primary Console With Em-Tec Adult Flow Probe. Date: 2024-06-14.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandABBOTT MEDICAL
Product2nd Generation CentriMag™ Primary Console With Em-Tec Adult Flow Probe
IssueMedical devices - Performance
Recall classType II
IdentificationRA-75670

Affected products

Product2nd Generation CentriMag™ Primary Console With Em-Tec Adult Flow Probe
LotMore than 10 numbers, contact manufacturer.
Model201-90421
Serial numberMore than 10 numbers, contact manufacturer.
Description2nd Generation CentriMag™ Primary Console With Em-Tec Adult Flow Probe

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Cardiovascular
CompaniesAbbott Medical 6035 Stoneridge Drive, Pleasanton, California, United States, 94588
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-75670
Background{}
CompaniesAbbott Medical 6035 Stoneridge Drive, Pleasanton, California, United States, 94588
AudiencesHealthcare
Source updated2024-06-14

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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