FDA recall Z-1846-2019

GE Healthcare, LLC · Class I · device

Product

Giraffe 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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1846-2019