Z-1547-2014Class II

Giraffe Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to...

Name: Z-1547-2014 Giraffe Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to...
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 Giraffe Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with... 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-1547-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-02
Posted: 2014-05-06
Terminated: 2016-05-11
Recalling firm: GE Healthcare
Product: 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).
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: 50 units
Distribution: Worldwide Distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1547-2014
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)