Philips North America Llc MPOClass I

Infant Heel Warmer (chemical Heat Pack)

Philips North America Llc's record for this product code

MDR events0All time

Recalls1All time

510(k) clearances0All time

Recent MDR events

0 adverse event reports on file

No MDR events on file for Philips North America Llc under this product code.

Recalls

1 recall events for this product code

Open, ClassifiedJan 19, 2022
After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.
View FDA record ↗

510(k) clearances

0 clearances for this product code

No 510(k) clearances on file for Philips North America Llc under this product code.