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Philips North America Llc recalls Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Recalled January 26, 2022 · FDA recall Z-0505-2022 · Philips North America
Hazard
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. · FDA Class II
Units
141,744 units (Updated to 141,750 units as of 2/15/22)
Sold at
US Nationwide and Canada
Description
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.
Product
Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Manufacturer(s)
Philips North America Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →