Lower riskMedical device recall · FDA · Published September 14, 2020
Philips Sterilizable Defibrillator Paddles Recall: Paddle Check Test Failure Risk
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.
Take action
Contact the company
📍Recalling firmPhilips North America, LLC3000 Minuteman Rd · Andover, MA 01810-1032
“Philips Sterilizable Defibrillator Paddles Recall: Paddle Check Test Failure Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64291-philips-sterilizable-defibrillator-paddles-recall-paddle-check-test-failure-risk. Based on FDA recall #Z-0284-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0284-2021%22&limit=1).
The FDA announced on 2020-09-14 that Philips North America, LLC is recalling its Sterilizable Defibrillator Paddles due to a failure detection hazard. The agency stated the recall addresses a Class II voluntary issue involving specific model numbers distributed globally.
According to the FDA, the periodic Paddle Checks recommended in the Instructions for Use may not detect one failure mode for the Switched Internal Defibrillator Paddles. The record states Philips has created an addendum to the IFU that includes a test for the switched paddles only to detect this failure mode.
Context
GovInfoNow's records show Philips North America Llc has had 129 other recalls on record since 2017-07-12. Recent brand recalls include an MR 5300 Model Number recall on 2026-08-21 and a Spectral CT 7500 Scanner recall on 2026-08-18. Other recent recalls of similar products include the Philips Allura Xper FD10C Medical System Recall on 2025-12-15, the Medline Convenience Kits Recall on 2026-01-07, and the Philips Allura Xper FD10F Medical System Recall on 2025-12-15.
How to tell if you have this one
Check for model numbers M4741A, M4742A, M4743A, or M4744A on the paddles. These paddles were manufactured and distributed from January 2015 through August 2020.
Brand
Philips
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Global Distribution. US Nationwide.
Recall number
Product, codes & lots
Quantity
Z-0284-2021
Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Numbers M4741A, M4742A, M4743A, M4744A - 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.; All units manufactured and distributed January 2015 to August 2020.
8,942
Z-0285-2021
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.; All units manufactured and distributed January 2015 to August 2020.
2,202
Based on the official FDA remedy
What to do — step by step
Check Paddle Model
Identify the model number on the paddles to confirm if they are M4741A, M4742A, M4743A, or M4744A.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Global Distribution. US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0284-2021 (September 14, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0284-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.