FDA Device recall Z-1847-2019
Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regula…
- FDA Device
- Class I
- terminated
- Published 2019-07-17
On 2019-07-17 the FDA classified a Class I recall of Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regula… by Ge Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1847-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-03-15 |
| Published | 2019-07-17 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ge Healthcare |
| Distribution | US |
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
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.
Identifiers
| code_info | Model Number, (Serial Number, UDI Number): M1112198-526438 (PBWX70184, 010084068210392321GBWX7012911180423); M11121…Model Number, (Serial Number, UDI Number): M1112198-526438 (PBWX70184, 010084068210392321GBWX7012911180423); M1112198-526773 (PBWX71881, Not Applicable); M1112198-023402 (HDJQ51784, Not Applicable); M1112198-023402 (HDJQ51785, Not Applicable); M1112198-023402 (HDJQ51786, Not Applicable); M1112198-023402 (HDJQ51787, Not Applicable); M1112198-025399 (HDJR56841, Not Applicable); M1112198-025399 (HDJR56842, Not Applicable); M1112198-025399 (HDJR56843, Not Applicable); M1112198-025399 (HDJR56844, Not Applicable); M1112198-025399 (HDJR56845, Not Applicable); M1112198-025399 (HDJR56846, Not Applicable); M1112198-025399 (HDJR56847, Not Applicable); M1112198-025399 (HDJR56848, Not Applicable); M1112198-025399 (HDJR56849, Not Applicable); M1112198-025399 (HDJR56850, Not Applicable); M1112198-025399 (HDJR56851, Not Applicable); M1112198-025399 (HDJR56852, Not Applicable); M1112198-025399 (HDJR56853, Not Applicable); M1112198-165184 (HDJS50 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1847-2019%22
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