Z-1549-2014Class II

Panda Freestanding Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are...

Name: Z-1549-2014 Panda Freestanding Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are...
Creator: GE Healthcare
Published: 2014-04-02
License: https://open.fda.gov/license/

GE Healthcare / initiated 2014-04-02 / Terminated / root cause: software

FDA source

GE Healthcare began a recall of Panda Freestanding Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own... on 2014-04-02. FDA classified it as Class II and gives the reason 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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1549-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-02
Posted: 2014-05-06
Terminated: 2016-05-11
Recalling firm: GE Healthcare
Product: 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).
Product code: FMT Warmer, Infant Radiant
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.
Root cause tag: software
FDA root cause: Software design
Action: GE Healthcare notified Biomedical/Clinical Engineering managers, Labor & Delivery/ NICU Nurse managers, Respiratory Therapy Managers and Directors of Risk Management by letter 04/02/2014. End users were advised that they may continue to use the system provided they follow the GE recommended actions: 1) If in use with a patient, turn off the Nellcor SpO2 function in the control panel and switch to an approved alternate form of SpO2 measurement. 2) Prior to using the affected GE warmer with the Nellcor SpO2 function, or resuming the use of this function with any patient, contact your hospital Bio-Med or qualified technician to check the Nellcor SpO2 alarm functionality using either an adult Nellcor SpO2 sensor or a Nellcor SpO2 simulator following the applicable instructions in the Appendix 3) If the test activates a Low Pulse Rate alarm, the user-adjusted Nellcor SpO2 alarm limits are functioning properly and the warmer can be placed back in clinical service. End users were also advised that alarm functionality must be re-checked following every service event requiring access to the internal electronics and during annual preventative maintenance, until revised software is installed. 4) If the test does NOT activate a Low Pulse Rate alarm, remove the warmer from clinical service and contact your local GE Healthcare Service Representative.
Quantity in commerce: 21 units
Distribution: Worldwide Distribution.
Product codes and lots: HDJS51142 HDJS52094 HDJS52095 HDJS52153 HDJS52154 HDJS52155 HDJS52156 HDJS52223 HDJS52224 HDJS52517 HDJS52518 HDJS52519 HDJS52520 HDJS52521 HDJS52522 HDJS52974 HDJS52975 HDJS52976 HDJS52977 HDJS52978 HDJS52979

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1549-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1547-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-14	2014-05-06
Z-1548-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-14	2014-05-06
Z-1549-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-14	2014-05-06
Z-1550-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-14	2014-05-06
Z-1551-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-14	2014-05-06

Product code FMT

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)