CLASS II Device recall · Reported 4 Nov 2020 · FDA Enforcement Report

Philips Sterilizable Defibrillator Paddles recalled

Philips North America is recalling Philips Sterilizable Defibrillator Paddles, Switchless Internal Paddles, distributed nationwide in the US. The recall was initiated on 14 Sep 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll units manufactured and distributed January 2015 to August 2020.

Quantity recalled2,202

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0285-2021
FDA event ID: 86441
Recalling firm: Philips North America, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 14 Sep 2020
FDA classified: 23 Oct 2020
Reported: 4 Nov 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Pacemakers & Defibrillators

Timeline

14 Sep 2020	Recall initiated by company
23 Oct 2020	Classified by FDA	+39 days
4 Nov 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

Global Distribution. US Nationwide.

Nationwide

Questions about this recall

Is Philips Sterilizable Defibrillator Paddles, Switchless Internal Paddles recalled?

Yes. Philips North America recalled Philips Sterilizable Defibrillator Paddles, Switchless Internal Paddles on 14 Sep 2020. The recall is Class II and its status is Terminated. Recall number Z-0285-2021.

Why was it recalled?

Which lots are affected?

All units manufactured and distributed January 2015 to August 2020.

Where was it sold?

Global Distribution. US Nationwide.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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