Class 2 Device Recall Infatherm Infant Transport Mattress; Model Number 989805616831

• Date Initiated by Firm: November 26, 2021
• Date Posted: January 18, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0505-2022
• Recall Event ID: 89173
• 510(K)Number: K936084
• Product Classification: Pack, hot or cold, disposable - Product Code IMD
• Product: Infa-Therm Transport Mattress, Reference Number 989805616831 1015
• Code Information: All units are impacted
• Recalling Firm/ Manufacturer: Philips North America Llc; 222 Jacobs St; Cambridge MA 02141-2289
• Manufacturer 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.
• FDA Determined Cause: No Marketing Application
• Action: 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.
• Quantity in Commerce: 141,744 units (Updated to 141,750 units as of 2/15/22)
• Distribution: US Nationwide and Canada
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = IMD