Infa-Therm Transport Mattress, Reference Number 989805616831 1015

FDA device recall Z-0505-2022 · posted 2022-01-18 · Open, Classified

Recall details

Recalling firm

Philips North America Llc

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.

Action taken

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.

Root cause

No Marketing Application

Status

Open, Classified

Product code

IMD

Quantity affected

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

Distribution

US Nationwide and Canada

Date initiated

2021-11-26

Date posted

2022-01-18

Location

Cambridge, MA

Related 510(k) clearances