—#190698

Product

Infa-Therm Transport Mattress, Reference Number 989805616831 1015

FDA product code: IMD — Pack, Hot Or Cold, Disposable
Device class: Class 1
Medical specialty: Physical Medicine
510(k) numbers: K936084
Affected lot / code info: All units are impacted

Why it was recalled

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.

Root cause (FDA determination)

No Marketing Application

Action the firm took

An URGENT Medical Device Recall notification letter dated November 2021 was distributed to customers. The actions that should be taken by the customer / user to prevent risks to patients or users: 1. Identify all Infa-Therm Transport Mattress in your possession. 2. Destroy all Infa-Therm Transport Mattress, regardless 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. 4. Identify and source an alternative device to meet your needs. Philips will no longer offer the Infa-Therm Transport Mattress. 5. Share this communication with your staff and other impacted departments and organizations. Actions planned by Philips to correct the problem: We understand that this may be an inconvenience to you. Philips will reimburse you for the quantity of the lnfa-Therm Transport Mattresses destroyed. If you need any further information concerning this issue, please email infantWarming@Philips.com (preferred communication path) or contact +1-629-215-7280 Monday through Friday, 8AM -3PM Central Standard Time. If you email infantWarming@Philips.com, you will receive an email response with the link to submit your Recall Acknowledgement form online, as well as a response to your inquiry.

Recalling firm

Firm: Philips North America Llc
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2289

Distribution

Distribution pattern: US Nationwide and Canada

Timeline

Recall initiated: 2021-11-26
Posted by FDA: 2022-01-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #190698. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.