Class 2 Device Recall Philips Sterilizable Defibrillator Paddles

• Date Initiated by Firm: September 14, 2020
• Create Date: October 23, 2020
• Recall Status: Terminated on September 13, 2022
• Recall Number: Z-0285-2021
• Recall Event ID: 86441
• 510(K)Number: K031187
• Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ
• Product: Philips Sterilizable Defibrillator Paddles, Switchless Internal Paddles, Model Numbers M1741A, M1742A, M1743A, M1744A - Product Usage: used in pairs to transmit a controlled electrical shock from an external defibrillator directly to the exposed heart muscle of a post-pubescent patient in order to intentionally stop start the heartbeat during cardiopulmonary surgery.
• Code Information: All units manufactured and distributed January 2015 to August 2020.
• Recalling Firm/ Manufacturer: Philips North America, LLC; 3000 Minuteman Rd; Andover MA 01810-1032
• Manufacturer Reason for Recall: The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator Paddles may not detect one failure mode for the Switched Internal Defibrillator Paddles. Philips has created an addendum to the IFU, that includes a test for the switched paddles only, which will detect this failure mode.
• FDA Determined Cause: Device Design
• Action: Urgent Medical Device Correction notification letters dated 9/4/20 were sent to customers. Insert a copy of the attached Instructions for Use Addendum: Sterilizable Defibrillator Paddles: Insulation Resistance Check for Switched Internal Paddles to the Sterilizable Defibrillator Paddles IFU. Follow the Instructions for Use, Paddles Checks section. The Paddle Checks activities include: Mechanical Check, Visual Inspection, Functional Check, Continuity Check, and Insulation Resistance Check. Perform these activities to confirm the paddles are safe and ready for use. The Insulation Resistance Test is to be applied only to Switched Internal Paddles (M4741A, M4742A, M4743A, and M4744A). Continue to perform the Paddles Checks activities as recommended in the IFU, before use as this reduces the risk of a failure as the paddles age. If your Internal Paddles fail any of these Paddle Checks, the IFU directs that the paddles should be removed from service and replaced. To acknowledge receipt of this notification, please complete and fax the Customer Reply Form to: +1.877.499.7223 or email to recalI.response@phiIips.com. If you need further information or support concerning this notification, please contact your local Philips representative or call us at 1-800-722-9377. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs Med Watch Adverse Event Reporting program either online, by regular mail or by fax.
• Quantity in Commerce: 2,202
• Distribution: Global Distribution. US Nationwide.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS