Medical Device Recall: Z-0505-2022

FDA Recalls dataset · Firm: Philips North America Llc · Status: Open, Classified

Recall Action Class: N/A Date Initiated: 2021-11-26 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0505-2022.

Recall Res Number
Z-0505-2022
Recalling Firm / Manufacturer
Philips North America Llc
FEI Number
3016618143
Recall Status
Open, Classified
Recall Classification
N/A
Date Initiated
2021-11-26
Date Posted
2022-01-18
Date Terminated
N/A
Product Code
IMD
Event Number
89173
Product Quantity
141,744 units (Updated to 141,750 units as of 2/15/22)
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.
Action Details 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.
Distribution Pattern US Nationwide and Canada
Code Information / Serial Numbers All units are impacted

Related Establishments / Registrations

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