CLASS II Device recall · Reported 14 May 2014 · FDA Enforcement Report

Giraffe¿ Infant Warmers integrated with Nellcor SpO2 recalled

GE Healthcare is recalling Giraffe¿ Infant Warmers integrated with Nellcor SpO2. The recall was initiated on 2 Apr 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesHDJM50062 HDJM50093 HDJM50470 HDJM50654 HDJM51812 HDJS55099 HDJS53396 HDJS53397 HDJS53398 HDJT50393 HDJS55036 HDJS55037 HDJS55038 HDJT50318 HDJS52165 HDJS52166 HDJS52119 HDJS52120 HDJR57563 HDJR57564 HDJR57565 HDJR57566 HDJR57567 HDJR57568 HDJR57569 HDJS50733 HDJS52092 HDJS52093 HDJS51002 HDJS51003 HDJS51004 HDJS51005 HDJS51006 HDJP50601 HDJP50606 HDJN50376 HDJS50790 HDJS50791 HDJS50792 HDJS50159 HDJS50160 HDJS51426 HDJS51427 HDJS50734 HDJS50735 HDJS52118 HDJT50534 HDJT50039 HDJR58198 HDJS50316

Quantity recalled50 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1547-2014
FDA event ID: 68067
Recalling firm: GE Healthcare, Laurel, MD
Classification: Class II
Status: Terminated
Recall initiated: 2 Apr 2014
FDA classified: 6 May 2014
Reported: 14 May 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

2 Apr 2014	Recall initiated by company
6 May 2014	Classified by FDA	+34 days
14 May 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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 (measured by a SpO2 sensor).

Where it was distributed

Worldwide Distribution.

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

HDJM50062 HDJM50093 HDJM50470 HDJM50654 HDJM51812 HDJS55099 HDJS53396 HDJS53397 HDJS53398 HDJT50393 HDJS55036 HDJS55037 HDJS55038 HDJT50318 HDJS52165 HDJS52166 HDJS52119 HDJS52120 HDJR57563 HDJR57564 HDJR57565 HDJR57566 HDJR57567 HDJR57568 HDJR57569 HDJS50733 HDJS52092 HDJS52093 HDJS51002 HDJS51003 HDJS51004 HDJS51005 HDJS51006 HDJP50601 HDJP50606 HDJN50376 HDJS50790 HDJS50791 HDJS50792 HDJS50159 HDJS50160 HDJS51426 HDJS51427 HDJS50734 HDJS50735 HDJS52118 HDJT50534 HDJT50039 HDJR58198 HDJS50316

Where was it sold?

Worldwide Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 68067

This product is part of a recall event; the main page for the event is Panda¿ iRes Infant Warmers integrated with Nellcor SpO2 recalled.

Reported	Class	Recall	Company	Reason	Where
14 May 2014	CLASS II	Panda¿ iRes Infant Warmers integrated with Nellcor SpO2 recalled	GE Healthcare	Device Malfunction	MD
14 May 2014	CLASS II	Panda¿ Freestanding Infant Warmers, integrated with Nellcor SpO2 recalled	GE Healthcare	Device Malfunction	MD
14 May 2014	CLASS II	Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 recalled	GE Healthcare	Device Malfunction	MD
14 May 2014	CLASS II	Panda¿ Wall-Mount Infant Warmers, integrated with Nellcor SpO2 recalled	GE Healthcare	Device Malfunction	MD

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