Philips recalls sterilizable defibrillator internal paddles that may wear out and fail to deliver therapy during cardiac emergencies. Users must follow operational checks to ensure safety.
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.
Philips is recalling sterilizable defibrillator internal paddles that may wear out over time and fail to deliver therapy. If not properly checked, these paddles could not stop or restart a patient's heartbeat during critical medical procedures.
The paddles can wear out and become damaged, which may prevent them from delivering the necessary electrical shock to the heart. This risk increases if users do not follow the manufacturer's operational checks to ensure the paddles are safe for use.
Healthcare professionals using Philips defibrillators with specific paddle models are most at risk. Patients undergoing cardiac surgery may also be affected if paddles fail during emergencies.
Check the paddle model numbers: Switchless models M1741A, M1742A, M1743A, M1744A and Switched models M4741A, M4742A, M4743A, M4744A. These paddles are sold with Philips defibrillators for cardiac surgery use.
Check the paddles according to the manufacturer's Instructions for Use to ensure they are safe for each use.
The paddles may wear out over time and fail to deliver therapy if not properly checked, which could be dangerous during cardiac emergencies.
Check the model numbers: Switchless models M1741A, M1742A, M1743A, M1744A and Switched models M4741A, M4742A, M4743A, M4744A.
No, but you must follow the operational checks in the Instructions for Use to ensure they are safe for each use.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-2134-2020 — Philips Philips Hello, I own a Philips that is covered by recall Z-2134-2020 from Philips. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
