Class 2 Device Recall Panda iRes Infant Warmers integrated with Nellcor SpO2

• Date Initiated by Firm: April 02, 2014
• Date Posted: May 06, 2014
• Recall Status: Terminated on May 11, 2016
• Recall Number: Z-1548-2014
• Recall Event ID: 68067
• 510(K)Number: K123309 K122267
• Product Classification: Warmer, infant radiant - Product Code FMT
• Product: Panda¿ iRes 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).
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• Recalling Firm/ Manufacturer: GE Healthcare; 8880 Gorman Rd; Laurel MD 20723-5800
• For Additional Information Contact: James 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: 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: 723 units
• Distribution: Worldwide Distribution.
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = FMT and Original Applicant = OHMEDA MEDICAL; 510(K)s with Product Code = FMT and Original Applicant = OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC.,