The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0483-2019·Announced 2018-11-28

GE Healthcare Recalls Panda Freestanding Infant Warmers Due to Electric Leakage

GE Healthcare is recalling 1,724 Panda Freestanding Infant Warmers worldwide due to a potential electric leakage hazard that could affect users.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential electric leakage (risk of harm) without reported injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

GE Healthcare, LLC is recalling 1,724 units of the Panda Freestanding Warmer, also sold as the Panda Freestanding Warmer Generic ATO Model. These devices are infant radiant warmers used in medical settings. The recall is being conducted by the U.S. Food and Drug Administration (FDA) under recall number Z-0483-2019.

The recall is due to a potential electric leakage issue that could affect the user. The source text does not specify the exact nature of the leakage or any reported injuries or illnesses associated with the defect.

The affected devices were distributed worldwide, including in the United States and numerous international markets such as Canada, the United Kingdom, Germany, and Japan. Specific model numbers and serial numbers are listed in the official recall documentation. Users of these devices should contact GE Healthcare for further instructions on how to address the potential hazard.

The recalled product

Product
Panda Freestanding Warmer. Device sold under the following product names: Panda Freestanding Warmer and Panda Freestanding Warmer Generic ATO Model. Infant Radiant warmer.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Infant Radiant Warmer
Hazard
Affected units
1,724

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model Number
  • UDI (Serial Number): 2063568-001-535551
  • 010084068210391621PFSX7006711180626 (PFSX70067)
  • 2063568-001-289325
  • Not Applicable (HDJT51400)
  • Not Applicable (HDJT51401)
  • 2063568-001-528373
  • 010084068210391621PFSX7005911180618 (PFSX70059)
  • 2063568-001-529111
  • 010084068210391621PFSX7008111180731 (PFSX70081)
  • 2063568-001-501555
  • 010084068210391621PFSV6011411161219 (PFSV60114)
  • 2063568-001-562946
  • 010084068210391621PFSX7005011180503 (PFSX70050)
  • 2063568-001-297793
  • Not Applicable (HDJT51542)
  • 2063568-001-533799
  • 010084068210391621PFSW60069170515 (PFSW60069)
  • 2063568-001-347865
  • Not Applicable (HDJT61189)

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · GE Healthcare, LLC

See all →

Same hazard · electric leakage

See all →

Similar recalls