Recall Z-0913-2014— GE Healthcare
Class II · Terminated
Class II FDA medical device recall by GE Healthcare, initiated 2013-12-12, terminated 2015-06-01. It names one FDA 510(k) clearance: K123309. Product: Panda iRes¿ Infant Warmers, part number M1112198 and Panda Freestanding Warmers, part number 2063568, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com** Panda Infant Warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.. Reason: Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients..
- Recalling firm
- GE Healthcare
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-12-12
- Terminated
- 2015-06-01
- Firm location
- Laurel, MD, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Panda iRes¿ Infant Warmers, part number M1112198 and Panda Freestanding Warmers, part number 2063568, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com** Panda Infant Warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.
Reason for recall
Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
Data sourced from openFDA. This site is unofficial and independent of the FDA.