FDA Device recall Z-0482-2019
Panda iRes Infant Radiant Warmer
- FDA Device
- Class II
- terminated
- Published 2018-11-28
On 2018-11-28 the FDA classified a Class II recall of Panda iRes Infant Radiant Warmer by Ge Healthcare, citing potential electric leakage affecting the user.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0482-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-25 |
| Published | 2018-11-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded Warmer.
Reason
Potential electric leakage affecting the user.
Identifiers
| code_info | Model Number, UDI (Serial Number): M1112198-526395, 010084068210389321PBWX7040911180413 (PBWX70409); M1112198-16465…Model Number, UDI (Serial Number): M1112198-526395, 010084068210389321PBWX7040911180413 (PBWX70409); M1112198-164657, Not Applicable (HDJT50683); M1112198-018125, Not Applicable (HDJM50048); M1112198-023789, Not Applicable (HDJM50529); M1112198-023787, Not Applicable (HDJM50528); M1112198-027124, Not Applicable (HDJP50065); M1112198-018125, Not Applicable (HDJM50047); M1112198-022592, Not Applicable (HDJM50596); M1112198-023488, Not Applicable (HDJQ50744); M1112198-024139, Not Applicable (HDJQ50819); M1112198-023359, Not Applicable (HDJR50385); M1112198-023359, Not Applicable (HDJR50389); M1112198-023359, Not Applicable (HDJR50382); M1112198-171607, Not Applicable (HDJS50605); M1112198-023391, Not Applicable (HDJM50439); M1112198-052019, Not Applicable (HDJR50487); M1112198-018105, Not Applicable (HDJM50140); M1112198-018105, Not Applicable (HDJM50139); M1112198-019900, Not Applicable (HDJM50471); M1112198-018105, Not Applicable |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0482-2019%22
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