# FDA recall Z-0285-2021

> **Philips North  America, LLC** · Class II · device recall initiated 2020-09-14.

## Product

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.

## 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.

## Distribution

Global Distribution.  US Nationwide.

## Key facts

- **Recall number:** Z-0285-2021
- **Recalling firm:** Philips North  America, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-09-14
- **Report date:** 2020-11-04
- **Termination date:** 2022-09-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0285-2021

## Citation

> AI Analytics. FDA recall Z-0285-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0285-2021. Source: US FDA. Licensed CC0.

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