Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Reported: January 26, 2022 Initiated: November 26, 2021 #Z-0505-2022
Product Description
Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Reason for Recall
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.
Details
- Recalling Firm
- Philips North America Llc
- Units Affected
- 141,744 units (Updated to 141,750 units as of 2/15/22)
- Distribution
- US Nationwide and Canada
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
Infa-Therm Transport Mattress, Reference Number 989805616831 1015. Recalled by Philips North America Llc. Units affected: 141,744 units (Updated to 141,750 units as of 2/15/22).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 26, 2022. Severity: Moderate. Recall number: Z-0505-2022.
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