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

Panda¿ Freestanding Infant Warmers, integrated with Nellcor SpO2 recalled

GE Healthcare is recalling Panda¿ Freestanding 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 codesHDJS51142 HDJS52094 HDJS52095 HDJS52153 HDJS52154 HDJS52155 HDJS52156 HDJS52223 HDJS52224 HDJS52517 HDJS52518 HDJS52519 HDJS52520 HDJS52521 HDJS52522 HDJS52974 HDJS52975 HDJS52976 HDJS52977 HDJS52978 HDJS52979

Quantity recalled21 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-1549-2014
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

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 rate (measured by a SpO2 sensor).

Where it was distributed

Worldwide Distribution.

Questions about this recall

Is Panda¿ Freestanding Infant Warmers, integrated with Nellcor SpO2 recalled?

Yes. GE Healthcare recalled Panda¿ Freestanding Infant Warmers, integrated with Nellcor SpO2 on 2 Apr 2014. The recall is Class II and its status is Terminated. Recall number Z-1549-2014.

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?

HDJS51142 HDJS52094 HDJS52095 HDJS52153 HDJS52154 HDJS52155 HDJS52156 HDJS52223 HDJS52224 HDJS52517 HDJS52518 HDJS52519 HDJS52520 HDJS52521 HDJS52522 HDJS52974 HDJS52975 HDJS52976 HDJS52977 HDJS52978 HDJS52979

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

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