CLASS II Device recall · Reported 28 Nov 2018 · FDA Enforcement Report

Panda Freestanding Warmer recalled by GE Healthcare

GE Healthcare is recalling Panda Freestanding Warmer, distributed nationwide in the US. The recall was initiated on 25 Sep 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number, UDI (Serial Number): 2063568-001-535551, 010084068210391621PFSX7006711180626 (PFSX70067); 2063568-001-289325, Not Applicable (HDJT51400); 2063568-001-289325, 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); 2063568-001-533888, 010084068210391621PFSW6007111170515 (PFSW60071); 2063568-001-533888, 010084068210391621PFSW6007011170515 (PFSW60070); 2063568-001-533888, 010084068210391621PFSW6007211170515 (PFSW60072);

Quantity recalled1,724 devices total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0483-2019
FDA event ID: 81224
Recalling firm: GE Healthcare, Waukesha, WI
Classification: Class II
Status: Terminated
Recall initiated: 25 Sep 2018
FDA classified: 19 Nov 2018
Reported: 28 Nov 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

25 Sep 2018	Recall initiated by company
19 Nov 2018	Classified by FDA	+55 days
28 Nov 2018	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential electric leakage affecting the user.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Panda Freestanding Warmer. Device sold under the following product names: Panda Freestanding Warmer and Panda Freestanding Warmer Generic ATO Model. Infant Radiant warmer.

Where it was distributed

Worldwide distribution. US Nationwide, Algeria, Australia, Austria, Belgium, Canada, Chile, China, Costa Rica, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Honduras, India, Indonesia, Ireland, Italy, Japan, Kazakhstan, Korea, Lithuania, Mexico, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.

Nationwide

Questions about this recall

Is Panda Freestanding Warmer recalled?

Yes. GE Healthcare recalled Panda Freestanding Warmer on 25 Sep 2018. The recall is Class II and its status is Terminated. Recall number Z-0483-2019.

Why was it recalled?

Potential electric leakage affecting the user.

Which lots are affected?

Model Number, UDI (Serial Number): 2063568-001-535551, 010084068210391621PFSX7006711180626 (PFSX70067); 2063568-001-289325, Not Applicable (HDJT51400); 2063568-001-289325, 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); 2063568-001-533888, 010084068210391621PFSW6007111170515 (PFSW60071); 2063568-001-533888, 010084068210391621PFSW6007011170515 (PFSW60070); 2063568-001-533888, 010084068210391621PFSW6007211170515 (PFSW60072);

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from GE Healthcare

All 512

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026Device	CLASS II	Signa Premier systems recalled by GE Healthcare	GE Healthcare	Other	Nationwide
11 Mar 2026Device	CLASS II	Centricity Universal Viewer Zero Footprint Client recalled	GE Healthcare	Device Malfunction	Nationwide
24 Dec 2025Device	CLASS II	GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological recalled	GE Healthcare	Device Malfunction
9 Apr 2025Device	CLASS II	Centricity Pacs-iw (Pacs-iw) recalled by GE Healthcare	GE Healthcare	Other	IL
9 Apr 2025Device	CLASS II	Centricity Centricity Pacs-iw with Universal Viewer recalled	GE Healthcare	Other	IL

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide