Z-0483-2019Class II

Panda Freestanding Warmer. Device sold under the following product names: Panda Freestanding Warmer and Panda...

Name: Z-0483-2019 Panda Freestanding Warmer. Device sold under the following product names: Panda Freestanding Warmer and Panda...
Creator: GE Healthcare, LLC
Published: 2018-09-25
License: https://open.fda.gov/license/

GE Healthcare / initiated 2018-09-25 / Terminated / root cause: manufacturing process

FDA source

GE Healthcare, LLC began a recall of Panda Freestanding Warmer. Device sold under the following product names: Panda Freestanding Warmer and Panda Freestanding Warmer Generic ATO Model. Infant... on 2018-09-25. FDA classified it as Class II and gives the reason as "Potential electric leakage affecting the user". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0483-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-25
Posted: 2018-11-19
Terminated: 2020-07-13
Recalling firm: GE Healthcare
Product: Panda Freestanding Warmer. Device sold under the following product names: Panda Freestanding Warmer and Panda Freestanding Warmer Generic ATO Model. Infant Radiant warmer.
Product code: FMT Warmer, Infant Radiant
Reason for recall: Potential electric leakage affecting the user.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: GE Healthcare notified customers on about 09/25/2018 via URGENT MEDICAL DEVICE CORRECTION letter. The letter indicated that the device could continue to be used along with good clinical practices. GE Healthcare will visit each location to perform the necessary testing. Until GE Healthcare can visit each site, instructions are to disconnect devices that use the USB (Giraffe OmniBed Carestation and Giraffe Incubator Carestation only) and the RS232 Nurse call ports, and inspect all power cords to ensure there is no damage to the cord or ground pin. GE Healtchare will perform necessary electrical safety test on all affected products and correct if required. A GE Healthcare representative will contact each customer to arrange for this test. For questions or concerns, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in commerce: 1,724 devices total
Distribution: 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.
Product codes and lots: 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);

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0483-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0479-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-28	2018-11-19
Z-0480-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-28	2018-11-19
Z-0481-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-28	2018-11-19
Z-0482-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-28	2018-11-19
Z-0483-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-28	2018-11-19
Z-0484-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-28	2018-11-19

Product code FMT

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)