GE Healthcare Integrated and Stand-Alone Resuscitation systems
Brand(s)
Last updated
Summary
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
Affected 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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
Datex-Ohmeda, Inc.
3114 N Grandview Blvd, Waukesha, Wisconsin, United States, 53188
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82212
Get notified
Receive emails about new and updated recall and safety alerts.