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Infa-Therm Transport Mattress, Reference Number 989805616831 1015

FDA Recall #Z-0505-2022 — Class II — November 26, 2021

Recall #Z-0505-2022 Date: November 26, 2021 Classification: Class II Status: Ongoing

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.

Recalling Firm

Philips North America Llc — Cambridge, MA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

141,744 units (Updated to 141,750 units as of 2/15/22)

Distribution

US Nationwide and Canada

Code Information

All units are impacted

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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