Panda¿ iRes Infant Warmers integrated with Nellcor SpO2
Medical device recall Z-1548-2014. Published in FDA’s Enforcement Report on May 14, 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 May 14, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 723 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 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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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).
723 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
HDJR50780 HDJR50781 HDJR56911 HDJR57608 HDJR57609 HDJR57610 HDJR57611 HDJR57636 HDJR57637 HDJR57638 HDJR57692 HDJR57693 HDJR57694 HDJR57695 HDJR57696 HDJR57697 HDJR57698 HDJR57699 HDJR57700 HDJR57701 HDJR57702 HDJR57703 HDJR57704 HDJR57705…
Every code shown here, 1,991 characters
HDJR50780 HDJR50781 HDJR56911 HDJR57608 HDJR57609 HDJR57610 HDJR57611 HDJR57636 HDJR57637 HDJR57638 HDJR57692 HDJR57693 HDJR57694 HDJR57695 HDJR57696 HDJR57697 HDJR57698 HDJR57699 HDJR57700 HDJR57701 HDJR57702 HDJR57703 HDJR57704 HDJR57705 HDJR57706 HDJR57707 HDJR57784 HDJR57785 HDJR57786 HDJR57787 HDJR57788 HDJR57789 HDJR57790 HDJR57791 HDJR57792 HDJR57793 HDJR57794 HDJR57795 HDJR57925 HDJR57926 HDJR57935 HDJR57936 HDJR57937 HDJR57938 HDJR57939 HDJR57944 HDJR57948 HDJR57949 HDJR57950 HDJR57951 HDJR57952 HDJR57953 HDJR57954 HDJR57955 HDJR57956 HDJR57957 HDJR57980 HDJR57981 HDJR57985 HDJR57986 HDJR57987 HDJR57988 HDJR58013 HDJR58014 HDJR58015 HDJR58039 HDJR58040 HDJR58041 HDJR58046 HDJR58047 HDJR58076 HDJR58082 HDJR58086 HDJR58087 HDJR58088 HDJR58091 HDJR58092 HDJR58093 HDJR58094 HDJR58095 HDJR58096 HDJR58097 HDJR58098 HDJR58099 HDJR58100 HDJR58101 HDJR58102 HDJR58103 HDJR58104 HDJR58105 HDJR58106 HDJR58107 HDJR58108 HDJR58109 HDJR58110 HDJR58111 HDJR58112 HDJR58113 HDJR58114 HDJR58115 HDJR58116 HDJR58117 HDJR58118 HDJR58137 HDJR58138 HDJR58156 HDJR58157 HDJR58158 HDJR58159 HDJR58160 HDJR58161 HDJR58162 HDJR58163 HDJR58164 HDJR58165 HDJR58192 HDJR58263 HDJR58264 HDJR58265 HDJR58267 HDJR58268 HDJR58269 HDJR58270 HDJR58271 HDJR58272 HDJR58273 HDJS50008 HDJS50009 HDJS50010 HDJS50011 HDJS50012 HDJS50013 HDJS50014 HDJS50015 HDJS50017 HDJS50018 HDJS50019 HDJS50020 HDJS50025 HDJS50026 HDJS50128 HDJS50129 HDJS50133 HDJS50134 HDJS50135 HDJS50136 HDJS50137 HDJS50144 HDJS50145 HDJS50146 HDJS50147 HDJS50148 HDJS50149 HDJS50150 HDJS50151 HDJS50152 HDJS50153 HDJS50154 HDJS501555 HDJS50205 HDJS50206 HDJS50238 HDJS50240 HDJS50241 HDJS50242 HDJS50243 HDJS50244 HDJS50245 HDJS50246 HDJS50247 HDJS50248 HDJS50249 HDJS50250 HDJS50251 HDJS50252 HDJS50253 HDJS50254 HDJS50337 HDJS50430 HDJS50432 HDJS50475 HDJS50476 HDJS50599 HDJS50600 HDJS50605 HDJS50606 HDJS50608 HDJS50609 HDJS50610 HDJS50611 HDJS50650 HDJS50670 HDJS50671 HDJS50672 HDJS50678 HDJS50679 HDJS50680 HDJS50682 HDJS50683…
FDA’s list runs to 7,230 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.
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Apr 2, 2014.
- FDA classified it on May 6, 2014.
- FDA’s Enforcement Report published it on May 14, 2014.
- FDA terminated it on May 11, 2016.
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 7,230 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.