Philips North America Llc 2022-01-26 Health serious FDA
Health · FDA · Recall #FDA-Z-0505-2022
Infa-Therm Transport Mattress, Reference Number 989805616831 1015 Recall
Issued January 26, 2022 · Philips North America Llc
In January 2022, Philips North America Llc recalled the Infa-Therm Transport Mattress, Reference Number 989805616831 1015, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using Infa-Therm Transport Mattress, Reference Number 989805616831 1015 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Philips North America Llc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Philips North America Llc
- Category
- Health
- Recall date
- January 26, 2022
- Units affected
- Not reported
- Sold at
- US Nationwide and Canada
- Recall number
- FDA-Z-0505-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Philips North America Llc has 34 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.