Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0505-2022 — Infa-Therm Transport Mattress, Reference Number 989805616831 1015

U.S. FDA — Device Enforcement · United States · 2021-11-26 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0505-2022
Date of alert
2021-11-26
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips North America Llc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
989805616831
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.