Philips Sterilizable Defibrillator Paddles — Class II medical device recall Z-0285-2021
Terminated recall by Philips North America, LLC, reported 2020-11-04, distributed nationwide. The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator Paddles may
| Recall number | Z-0285-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, LLC, Andover, MA, United States |
| Recall initiated | 2020-09-14 |
| Classified | 2020-10-23 |
| Reported by FDA | 2020-11-04 |
| Terminated | 2022-09-13 |
| Distributed | Nationwide (US) |
| Quantity | 2,202 |
| Model numbers | M1741A, M1742A, M1743A, M1744A |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0285-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.