Philips North America Llc Recall 89173
Description: Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Philips North America Llc Recall 89173 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0505-2022 |
| Event ID | 89173 |
| Event Description | Infa-Therm Transport Mattress, Reference Number 989805616831 1015 |
| Product Type | Devices |
| Distribution | US Nationwide and Canada |
| Quantity | 141,744 units (Updated to 141,750 units as of 2/15/22) |
| Recall Reason | 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. |
| Device Classification | 20220126 |
| Device Code Info | All units are impacted |
| Center Classification Date | 20220118 |
| Recall Initiation Date | 20211126 |
| Recalling Firm | Philips North America Llc |
| Initial Notification | Letter |
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