Public recall detail

GE Healthcare Integrated and Stand-Alone Resuscitation systems

2026-06-16

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Health products Health product recall
Quick summary

Quick summary: GE Healthcare Integrated and Stand-Alone Resuscitation systems. Reason: Health product recall. Category: Health products. Date: 2026-06-16.

Recommended action

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

Recall details

Quick summary: GE Healthcare Integrated and Stand-Alone Resuscitation systems. Reason: Health product recall. Category: Health products. Date: 2026-06-16.

Official details

Affected product details

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

BrandDatex-Ohmeda, Inc.
ProductGE Healthcare Integrated and Stand-Alone Resuscitation systems
IssueMedical devices - Performance
Recall classType II
IdentificationRA-82212

Affected products

ProductPanda Warmer With Integrated Resuscitation System (Ires)
LotPBWZ71728
ModelM1112198
Serial numberPBWZ71728
DescriptionPanda Warmer With Integrated Resuscitation System (Ires)
ProductGiraffe Warmer With Integrated Resuscitation System (Ires)
LotHDJT51537
ModelM1118179
Serial numberHDJT51537
DescriptionGiraffe Warmer With Integrated Resuscitation System (Ires)
ProductGiraffe Warmer With Integrated Resuscitation System (Ires)
LotHDJU65007
ModelM1118179
Serial numberHDJU65007
DescriptionGiraffe Warmer With Integrated Resuscitation System (Ires)
ProductGiraffe Warmer With Integrated Resuscitation System (Ires)
LotHDJU65440
ModelM1118179
Serial numberHDJU65440
DescriptionGiraffe Warmer With Integrated Resuscitation System (Ires)
ProductGiraffe Stand-Alone Infant Resuscitation System
LotSTPC70188
Model2082663-001
Serial numberSTPC70188
DescriptionGiraffe Stand-Alone Infant Resuscitation System
ProductPanda Warmer
LotPBW24120458SA
ModelM1112198
Serial numberPBW24120458SA
DescriptionPanda Warmer
ProductPanda Warmer
LotPBWY72937
ModelM1112198
Serial numberPBWY72937
DescriptionPanda Warmer
ProductPanda Warmer
LotPBW26048040SA
ModelM1112198
Serial numberPBW26048040SA
DescriptionPanda Warmer

Issue

GE HealthCare has become aware of a potential issue involving the air-oxygen blender knob shaft on certain (serial number specific) integrated and stand-alone Resuscitation systems. In some cases, the blender knob shaft can loosen, which can affect the delivered oxygen concentration. If this occurs, the system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - General hospital and personal use
CompaniesDatex-Ohmeda, Inc.3114 N Grandview Blvd, Waukesha, Wisconsin, United States, 53188
Recall date2026-06-01
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82212
Background{}
CompaniesDatex-Ohmeda, Inc.3114 N Grandview Blvd, Waukesha, Wisconsin, United States, 53188
AudiencesHealthcare
Source updated2026-06-16

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

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