Philips recalls sterilizable defibrillator paddles (models M4741A-M4744A) produced 2015-2020 due to potential failure in paddle checks during use. The addendum provides a specific test to detect this issue.
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 (models M4741A to M4744A) made between January 2015 and August 2020. The recall is because the standard paddle check test might miss a specific failure mode in these paddles, which could affect patient safety during cardiac procedures.
The standard paddle check test in the product's instructions might not detect a specific failure in the switched internal paddles. This could lead to improper electrical shock delivery during critical cardiac procedures if the failure occurs.
Healthcare professionals using these paddles in cardiac surgery settings are most at risk. Patients undergoing cardiopulmonary procedures with these paddles could be affected if the failure mode occurs.
Check for model numbers M4741A, M4742A, M4743A, or M4744A on the paddles. These paddles were manufactured and distributed from January 2015 through August 2020.
Identify the model number on the paddles to confirm if they are M4741A, M4742A, M4743A, or M4744A.
The standard paddle check test in the product's instructions might not detect a specific failure mode in these paddles, which could affect patient safety during cardiac procedures.
Check the model number on the paddles to see if they are M4741A, M4742A, M4743A, or M4744A. If so, contact Philips for the addendum to the instructions that includes a specific test to detect the failure mode.
The recall indicates a potential issue with the paddle check test that could lead to improper electrical shock delivery during cardiac procedures, but the risk is low as the addendum provides a specific test to detect the failure.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-0284-2021 — Philips Philips Hello, I own a Philips that is covered by recall Z-0284-2021 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.
