Panda iRes¿ Infant Warmers
Medical device recall Z-0913-2014. Published in FDA’s Enforcement Report on Feb 12, 2014.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Feb 12, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 9232 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
9232 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: HDJQ52826 HDJR50704 HDJR54140 HDJR54141 HDJR54142 HDJR54143 HDJS50670 HDJS50671 HDJS50672 HDJS50678 HDJS50679 HDJS50681 HDJS50682 HDJS50684 HDJS50686 HDJR56405 HDJS52316 HDJP51364 HDJP51369 HDJP51376 HDJP51379 HDJP51380…
Every code shown here, 1,996 characters
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 HDJS50505 HDJM50027 HDJL50483 HDJM50022 HDJM50024 HDJM50411 HDJS50708 HDJS52037 HDJR57284 HDJR57285 HDJN52002 HDJN50436 HDJN50437 HDJP50552 HDJP50553 HDJQ50808 HDJP50078 HDJP50083 HDJQ52336 HDJQ52337 HDJQ52036 HDJQ52037 HDJQ52038 HDJQ52039 HDJS51666 HDJP52689 HDJQ51784 HDJQ51785 HDJQ51786 HDJQ51787 HDJS50825 HDJS50826 HDJS50827 HDJS50828 HDJS50829 HDJS50830 HDJS50831 HDJS50832 HDJR56841 HDJR56842 HDJR56843 HDJR56844 HDJR56845 HDJR56846 HDJR56847 HDJR56848 HDJR56849 HDJR56850 HDJR56851 HDJR56852 HDJR56853 HDJS51131 HDJQ52031 HDJQ50663 HDJS50931 HDJS50932 HDJQ51956 HDJM50250 HDJM50251 HDJM50252 HDJM50253 HDJM50254 HDJM50255 HDJM52126 HDJM52127 HDJM52128 HDJM52129 HDJQ50066 HDJQ50067 HDJR50762 HDJR50763 HDJR50764 HDJR58093 HDJR58094 HDJR58095 HDJR52011 HDJR52012 HDJR54180 HDJR50307 HDJR50308 HDJR50309 HDJR50310 HDJS51721 HDJM51686 HDJM51687 HDJN51900 HDJN51901 HDJP51716 HDJS50570 HDJS50571 HDJS50572 HDJS50573 HDJM50391 HDJM50392 HDJP50523 HDJP50524 HDJP50525 HDJP50526 HDJP50527 HDJP50528 HDJL50044 HDJP50572 HDJP52345 HDJP52349 HDJP52350 HDJQ52153 HDJQ52154 HDJQ52155 HDJQ52156…
FDA’s list runs to 98,607 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Uruguay, Venezuela, Albania, Algeria, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Canada, Chile, China, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Kazakhstan, Korea, Kuwait, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates, and United Kingdom.
The states and territories these words name
- Puerto Rico
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 12, 2013.
- FDA classified it on Feb 3, 2014.
- FDA’s Enforcement Report published it on Feb 12, 2014.
- FDA terminated it on Jun 1, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, of Laurel, MD.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 98,607 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.