Recall Z-1551-2014 ยท FMT Warmer, Infant Radiant
GE Healthcare
Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part manufactured by a third party supplier; and an integral component of the Nellcor SpO2 device. 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 he
| Date | May 6, 2014 (initiated Apr 2, 2014) |
| Status | Terminated |
| Reason | 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 | 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 Bi |
| Quantity | 301 units |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.