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U.S. Department of Health and Human Services

Class 2 Device Recall Panda Freestanding Infant Warmers, integrated with Nellcor SpO2

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 Class 2 Device Recall Panda Freestanding Infant Warmers, integrated with Nellcor SpO2see related information
Date Initiated by FirmApril 02, 2014
Date PostedMay 06, 2014
Recall Status1 Terminated 3 on May 11, 2016
Recall NumberZ-1549-2014
Recall Event ID 68067
510(K)NumberK122267 K123309 
Product Classification Warmer, infant radiant - Product Code FMT
ProductPanda 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).
Code Information HDJS51142 HDJS52094 HDJS52095 HDJS52153 HDJS52154 HDJS52155 HDJS52156 HDJS52223 HDJS52224 HDJS52517 HDJS52518 HDJS52519 HDJS52520 HDJS52521 HDJS52522 HDJS52974 HDJS52975 HDJS52976 HDJS52977 HDJS52978 HDJS52979 
Recalling Firm/
Manufacturer		 GE Healthcare
8880 Gorman Rd
Laurel MD 20723-5800
For Additional Information ContactJames Dennison
800-345-2700
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionGE 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 Commerce21 units
DistributionWorldwide Distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FMT
510(K)s with Product Code = FMT
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