Recall MonitorHealth Products
GE Healthcare Integrated and Stand-Alone Resuscitation systems
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use
Product: GE Healthcare Integrated and Stand-Alone Resuscitation systems
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Panda Warmer With Integrated Resuscitation System (Ires) | PBWZ71728 | M1112198 |
| Giraffe Warmer With Integrated Resuscitation System (Ires) | HDJT51537 | M1118179 |
| Giraffe Warmer With Integrated Resuscitation System (Ires) | HDJU65007 | M1118179 |
| Giraffe Warmer With Integrated Resuscitation System (Ires) | HDJU65440 | M1118179 |
| Giraffe Stand-Alone Infant Resuscitation System | STPC70188 | 2082663-001 |
| Panda Warmer | PBW24120458SA | M1112198 |
| Panda Warmer | PBWY72937 | M1112198 |
| Panda Warmer | PBW26048040SA | M1112198 |
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.