CanadaCertain Datex‑Ohmeda Panda and Giraffe warmers and integrated or stand‑alone resuscitation systems are affected — look for model/catalogue numbers M1112198, M1118179, 2082663‑001 and serial numbers PBWZ71728, HDJT51537, HDJU65007, HDJU65440, STPC70188, PBW24120458SA, PBWY72937, PBW26048040SA. They were recalled because the air‑oxygen blender knob shaft can loosen and cause the delivered oxygen concentration to differ from the user setting, potentially resulting in hypoxia or hyperoxia. Contact the manufacturer for additional information.
What's being recalled
Companies: Datex-Ohmeda, Inc., 3114 N Grandview Blvd, Waukesha, Wisconsin, United States, 53188.
How to identify it
Affected products: Panda Warmer With Integrated Resuscitation System (Ires); Lot or serial number: PBWZ71728; Model or catalogue number: M1112198
Affected products: Giraffe Warmer With Integrated Resuscitation System (Ires); Lot or serial number: HDJT51537; Model or catalogue number: M1118179
Affected products: Giraffe Warmer With Integrated Resuscitation System (Ires); Lot or serial number: HDJU65007; Model or catalogue number: M1118179
Affected products: Giraffe Warmer With Integrated Resuscitation System (Ires); Lot or serial number: HDJU65440; Model or catalogue number: M1118179
Affected products: Giraffe Stand-Alone Infant Resuscitation System; Lot or serial number: STPC70188; Model or catalogue number: 2082663-001
Affected products: Panda Warmer; Lot or serial number: PBW24120458SA; Model or catalogue number: M1112198
Affected products: Panda Warmer; Lot or serial number: PBWY72937; Model or catalogue number: M1112198
Affected products: Panda Warmer; Lot or serial number: PBW26048040SA; Model or catalogue number: M1112198
The hazard
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 to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States