FDA Device recall Z-0505-2022
Infa-Therm Transport Mattress, Reference Number 989805616831 1015
- FDA Device
- Class II
- ongoing
- Published 2022-01-26
On 2022-01-26 the FDA classified a Class II recall of Infa-Therm Transport Mattress, Reference Number 989805616831 1015 by Philips North America, citing 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 b….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0505-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-11-26 |
| Published | 2022-01-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips North America |
| Distribution | US |
Product
Infa-Therm Transport Mattress, Reference Number 989805616831 1015
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.
Identifiers
| code_info | All units are impacted |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0505-2022%22
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