Public recall detail

Combolab AltiX

2023-08-21

medium
Recall Safety notice
Quick summary

Quick summary: Combolab AltiX. Date: 2023-08-21.

Recommended action

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

Recall details

Quick summary: Combolab AltiX. Date: 2023-08-21.

Official details

Affected product details

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

BrandGe Medical Systems Information Technologies Inc.
ProductCombolab AltiX
IssueMedical devices - Performance
Recall classType II
IdentificationRA-74139

Affected products

ProductCombolab AltiX
LotSVS23040008SA SVS23040003SA
Model2300000-005
Serial numberSVS23040008SA SVS23040003SA
DescriptionCombolab AltiX

Issue

GE Healthcare has become aware that a diode on the power supply of the Prucka 3 Amplifier used with cardiolab/combolab systems could reach elevated temperatures. This could cause the amplifier to fail and consequently power off and become inoperable. Recall Start Date: August 8, 2023

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Cardiovascular
CompaniesGE Medical Systems Information Technologies Inc. 9900 Innovation Drive, Wauwatosa, Wisconsin, United States, 53226
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-74139
Background{}
CompaniesGE Medical Systems Information Technologies Inc. 9900 Innovation Drive, Wauwatosa, Wisconsin, United States, 53226
AudiencesHealthcare
Source updated2023-08-21

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

Starting...

Related recalls

Similar recalls and safety notices.

Loading related recalls...