PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: November 28, 2018 Initiated: September 25, 2018 #Z-0483-2019

Product Description

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

Reason for Recall

Potential electric leakage affecting the user.

Details

Recalling Firm
GE Healthcare, LLC
Units Affected
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.
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled?
Panda Freestanding Warmer. Device sold under the following product names: Panda Freestanding Warmer and Panda Freestanding Warmer Generic ATO Model. Infant Radiant warmer.. Recalled by GE Healthcare, LLC. Units affected: 1,724 devices total.
Why was this product recalled?
Potential electric leakage affecting the user.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 28, 2018. Severity: Moderate. Recall number: Z-0483-2019.