Philips North America, LLC Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory to the compatible monitor/defibrillator Switchless: M1741A, M1742A, M1743A, M1744A Switched: M4741A, M4742A, M4743A, M4744A - Product Usage: An electrical conductor 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory to the compatible monitor/defibrillator Switchless: M1741A, M1742A, M1743A, M1744A Switched: M4741A, M4742A, M4743A, M4744A - Product Usage: An electrical conductor 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.
Brand
Philips North America, LLC
Lot Codes / Batch Numbers
All lots
Products Sold
All lots
Philips North America, LLC is recalling Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory to the compa due to Internal Paddles may wear over time and may not be safe or ready for use, unless the directions in the Instructions for Use (IFU) to perform routine o. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Internal Paddles may wear over time and may not be safe or ready for use, unless the directions in the Instructions for Use (IFU) to perform routine operational checks are followed. The instructions for use rely on these checks rather than specifying a maximum number of sterilization cycles to determine when the paddles should be discarded. A damaged Internal Paddle may not be able to deliver therapy.
Recommended Action
Per FDA guidance
Philips issued U.S. customer Field Safety Notification on 04/20/2020 via priority mail. Philips Markets Organizations are responsible for distributing the letters outside of the U.S.. Letter states reason for recall, health risk an action to take: Follow the Instructions for Use, Paddles Checks section. The Paddle Checks activities include; Mechanical Check, Visual Inspection, Functional Check, and Continuity Check. Perform these activities to confirm the paddles are safe and ready for use. Continue to perform the Paddles Checks activities as recommended in the IFU before use as this reduces the risk of a failure. If one or more of these Paddles Checks activities fail, you must remove them from service and replace the paddles. To acknowledge receipt of this notification, please complete and fax the Customer Reply Form to: +1.877.499.7223 or email to recall .response@philips.com. If you need further information or support concerning this notification, please AND SUPPORT contact your local Philips representative or call us at 1-800-722-9377
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026