FDA Device recall Z-0913-2014
Panda iRes¿ Infant Warmers, part number M1112198 and Panda Freestanding Warmers, part number 2063568, labeled in part *** GE Healthcare 888…
- FDA Device
- Class II
- terminated
- Published 2014-02-12
On 2014-02-12 the FDA classified a Class II recall of Panda iRes¿ Infant Warmers, part number M1112198 and Panda Freestanding Warmers, part number 2063568, labeled in part *** GE Healthcare 888… by Ge Healthcare, citing medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0913-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-12-12 |
| Published | 2014-02-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
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.
Identifiers
| code_info | Serial Numbers: HDJQ52826 HDJR50704 HDJR54140 HDJR54141 HDJR54142 HDJR54143 HDJS50670 HDJS50671 HDJS50672 HDJ…Serial Numbers: HDJQ52826 HDJR50704 HDJR54140 HDJR54141 HDJR54142 HDJR54143 HDJS50670 HDJS50671 HDJS50672 HDJS50678 HDJS50679 HDJS50681 HDJS50682 HDJS50684 HDJS50686 HDJR56405 HDJS52316 HDJP51364 HDJP51369 HDJP51376 HDJP51379 HDJP51380 HDJP51381 HDJR56387 HDJR56388 HDJR56389 HDJR56390 HDJR56391 HDJR56666 HDJN50977 HDJN50978 HDJQ53071 HDJM51282 HDJM51283 HDJM51284 HDJM51285 HDJM51286 HDJM51287 HDJM51288 HDJM51289 HDJM51290 HDJM51291 HDJM51292 HDJM51293 HDJM51294 HDJM51295 HDJQ50845 HDJQ50846 HDJQ50361 HDJQ50362 HDJQ50363 HDJQ50364 HDJQ50365 HDJQ52097 HDJM51403 HDJM51871 HDJP52195 HDJP52198 HDJP52199 HDJP52200 HDJP52201 HDJP52202 HDJP52203 HDJP52204 HDJP52205 HDJP52206 HDJP52207 HDJM50831 HDJM50832 HDJM50833 HDJS51808 HDJM50053 HDJM50054 HDJM50098 HDJM50099 HDJM50101 HDJM50103 HDJM50105 HDJM50124 HDJP50315 HDJP50369 HDJP50371 HDJR58044 HDJR58045 HDJP51614 HDJP51615 HDJN52372 HDJN52373 HDJS50504 HDJS |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0913-2014%22
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