RecallRadar

FDA Device recall Z-0482-2019

Panda iRes Infant Radiant Warmer

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

AgencyFDA Device
Recall numberZ-0482-2019
ClassificationClass II
Statusterminated
Initiated2018-09-25
Published2018-11-28
Last updated2026-09-13 11:54 UTC
CompanyGe Healthcare
DistributionUS

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

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.