Public recall detail

Cardiohelp-I

2024-04-08

medium
Recall Safety notice
Quick summary

Quick summary: Cardiohelp-I. Date: 2024-04-08.

Recommended action

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

Recall details

Quick summary: Cardiohelp-I. Date: 2024-04-08.

Official details

Affected product details

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

BrandMAQUET CARDIOPULMONARY GMBH
ProductCardiohelp-I
IssueMedical devices - Performance
Recall classType II
IdentificationRA-75365

Affected products

ProductCardiohelp-I
Lot90410131 90410130
Model70104.8012
Serial number90410131 90410130
DescriptionCardiohelp-I

Issue

During service measurements on the Cardiohelp-I devices in the field, it was noticed that the measured patient leakage current exceeded the limit values of 50 μa specified in standard EN 60601-1:2006 + a1:2013. Patient leakage currents of up to 1337 μa were measured. Investigations have shown that only Cardiohelp-I devices with installed sensor panels (701051308) with an old sensor bridge (701049193) hardware version are affected. The new hardware version is not affected. Recall Start Date: March 18, 2024

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Gastroenterology and urology
CompaniesMaquet Cardiopulmonary Gmbh Kehler Strasse 31, Rastatt, Germany, 76437
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-75365
Background{}
CompaniesMaquet Cardiopulmonary Gmbh Kehler Strasse 31, Rastatt, Germany, 76437
AudiencesHealthcare
Source updated2024-04-08

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

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