Food, drugs, devices › GE Healthcare
Device recall: Giraffe¿ Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regu
GE Healthcare (Laurel, MD) initiated this device recall on 2 Apr 2014; FDA lists 5 product records under event 68067, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 11 May 2016. Initiation: voluntary: firm initiated. GE Healthcare has 44 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
GE Healthcare, Laurel, MD.
Reason for recall
"Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver."
Distribution
"Worldwide Distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1547-2014 | Giraffe¿ Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate… | 50 units | Class II | Terminated | 14 May 2014 |
| Z-1548-2014 | Panda¿ iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate… | 723 units | Class II | Terminated | 14 May 2014 |
| Z-1549-2014 | Panda¿ Freestanding Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse… | 21 units | Class II | Terminated | 14 May 2014 |
| Z-1550-2014 | Panda¿ Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse… | 15 units | Class II | Terminated | 14 May 2014 |
| Z-1551-2014 | Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part manufactured by a third party supplier; and an integral component of the Nellcor SpO2 device. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for… | 301 units | Class II | Terminated | 14 May 2014 |
Context
Other enforcement events for GE Healthcare
All 44 events for GE Healthcare
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 11 May 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.