Z-1549-2014 Class II Terminated
FDA device recall Z-1549-2014 was initiated by GE Healthcare on Apr 2, 2014 and is designated Class II. 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. The recall status is terminated (terminated May 11, 2016). Affected quantity: 21 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 14, 2014
- Initiation Date
- Apr 2, 2014
- Termination Date
- May 11, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21 units
Product Description
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).
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 Pattern
Worldwide Distribution.
Code Information
HDJS51142 HDJS52094 HDJS52095 HDJS52153 HDJS52154 HDJS52155 HDJS52156 HDJS52223 HDJS52224 HDJS52517 HDJS52518 HDJS52519 HDJS52520 HDJS52521 HDJS52522 HDJS52974 HDJS52975 HDJS52976 HDJS52977 HDJS52978 HDJS52979
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1549-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026