Philips reminds Infa-Therm Transport Mattress customers in the US and Canada to cease use and destroy existing inventory as instructed by the November 26, 2021 recall notification

As part of this action, Philips contacted affected customers and distributors and instructed them to cease use of and to destroy affected products.

To help ensure ongoing customer awareness of this recall notification, Philips is posting this online notice.

Philips issued notification in November 2021, because changes were made to the product labeling, which were not within the scope of the product’s original 510(k) clearance. These labeling changes were related to maximum temperature, expiration date, and instructions for use. Philips made the business decision to discontinue manufacture and distribution. At the time of the notification, the product was no longer manufactured or distributed by Philips. In January 2022, the FDA designated this notification a Class II recall.

During the 13 years since 2009, Philips has filed four reports of accidental burns in the neonatal population. One of these four reports was later determined not to involve a Philips device, and one of these reports remains under investigation (MDR #1100070000-2022-0001).

If customers need any further information or support concerning this issue, they are advised to email [email protected].

If customers experience any adverse reactions or quality problems with the use of affected products, they may report adverse reactions or quality problems to the FDA’s MedWatch Adverse Event Reporting program either online (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1), by regular mail or by fax (1-800-332-0178).

Should customers continue to use their product?

No. Since December 2021, Philips is contacting and instructing customers to destroy affected products in accordance with the recall notification.

How can a customer identify a unit affected by this correction?

What should customers do if they have devices affected by this correction?

Customers should take the following steps:

2. Destroy all Infa-Therm Transport Mattresses, regardless of if they are expired or not.

3. Please complete the Urgent Medical Device Recall Response Form online by using the URL provided on the form.  The following link should be used to submit both your acknowledgement of this recall and actions taken, as well as request for credit: https://forms.office.com/r/zdRPY0Fth9.

4. Identify and source an alternative device to meet their needs. Philips is no longer distributing the Infa-Therm Transport Mattress.