FDAFDA · Food and drugs·Recall number Z-0505-2022
Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Published January 26, 2022 · Recall initiated: November 26, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips North America Llc
- Distributor
- US Nationwide and Canada
- Lot
- All units are impacted
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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