Recall Z-1846-2019 ยท FMT Warmer, Infant Radiant
GE Healthcare, LLC
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.
| Date | Jul 11, 2019 (initiated Mar 15, 2019) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | GE Healthcare notified customers on about 03/15/2019 via "URGENT MEDICAL DEVICE CORRECTION" letter. Customers were instructed to 1) Inspect the warmer bedside panels latch areas and the areas connecting the panel to the bed for any cracks or damages per the addendum included in the mailing. If any portion of the bedside panels or latches are cracked or broken, stop use of the warmer. Complete and return the attached response form in via FAX TO: +1-410-630-5579, or scanning or taking a photo of the completed form e-mailing to: MIC.Recall@ge.com indicating what components require replacement. |
| Quantity | 9,094 devices |
| 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 Island |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123309 | GIRAFFE AND PANDA WARMERS Ohmeda Medical, Feb 5, 2013 |