Panda Freestanding Warmer. Device sold under the recall
Panda Freestanding Warmer. Device sold under the following product names: Panda Freestanding Warmer and Panda Freestanding Warmer Generic ATO Model.…
Why was Panda Freestanding Warmer. Device sold under the recalled?
Potential electric leakage affecting the user.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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);
- Product
- Panda Freestanding Warmer. Device sold under the following product names: Panda Freestanding Warmer and Panda Freestanding Warmer Generic ATO Model.…
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 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.
- Recall date
- November 28, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)