# FDA recall Z-1847-2019

> **GE Healthcare, LLC** · Class I · device recall initiated 2019-03-15.

## Product

Panda Infant Radiant Warmer    Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment.

## Reason for recall

The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack or break if the unit is moved using the bedside panels instead of the front handle or the maneuvering handle.

## Distribution

Worldwide Distribution: US (Nationwide distribution) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Guam, Northern Mariana Islands; and to countries of: Albania, Algeria, Argentina, Aruba, Australia, , Austria, Azerbaijan, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bermuda, Bolivia, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Guam, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Korea (Republic of), Kuwait, Lebanon, Libya, Lithuania, Macau, Macedonia, Malaysia, Maldives, Mauritius, Mexico, Moldova, Myanmar, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, STATE OF, Panam

## Key facts

- **Recall number:** Z-1847-2019
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-15
- **Report date:** 2019-07-17
- **Termination date:** 2024-05-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukesha, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1847-2019

## Citation

> AI Analytics. FDA recall Z-1847-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1847-2019. Source: US FDA. Licensed CC0.

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