Reported Feb 12, 2014 · Terminated

Panda iRes¿ Infant Warmers, part number M1112198 and Panda Freestanding Warmers, part number 2063568, labeled in part…

GE Healthcare

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: GE Healthcare · 8880 Gorman Rd · Laurel, MD · 20723-5800

Is this the product you have?

  • 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.
Lot codes and dates
  • Serial Numbers

    2,962 of 2,962 codes

    • 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
    HD
Amount recalled
9232 units

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 1, 2015 · Data as of Sep 19, 4:52 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.