Philips recalls sterilizable defibrillator paddles (models M1741A-M1744A) produced 2015-2020. The paddle check test in instructions may miss a specific failure mode. Affected users should check if their paddles need a new test method.
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.
Philips is recalling sterilizable defibrillator paddles made between January 2015 and August 2020. The recall is because the standard paddle check test might not detect a specific failure in these paddles. This could affect patient safety during cardiac procedures.
The paddle check test in the instructions may not detect a specific failure mode in the paddles. This means the paddles might not work properly during critical cardiac procedures, potentially affecting patient safety.
Healthcare professionals using these paddles during cardiac surgery are most at risk. Patients undergoing cardiopulmonary procedures with these paddles could be affected.
Check for model numbers M1741A, M1742A, M1743A, or M1744A on the paddles. These paddles were made between January 2015 and August 2020 and used in cardiac surgery.
Look for model numbers M1741A, M1742A, M1743A, or M1744A on the paddles.
The paddle check test in the instructions may not detect a specific failure mode in these paddles.
Check the model numbers on the paddles. If they match M1741A-M1744A, contact Philips for the updated test method.
The recall is for a potential failure in the paddle check test, which could affect patient safety during cardiac procedures.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-0285-2021 — Philips Philips Hello, I own a Philips that is covered by recall Z-0285-2021 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.
