Philips Sterilizable Defibrillator Internal Paddles — Class II medical device recall Z-2134-2020
Terminated recall by Philips North America, LLC, reported 2020-06-03, distributed nationwide. Internal Paddles may wear over time and may not be safe or ready for use, unless the directions in the Instruc
| Recall number | Z-2134-2020 |
|---|---|
| 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 | 2020-04-20 |
| Classified | 2020-05-27 |
| Reported by FDA | 2020-06-03 |
| Terminated | 2021-04-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DO, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HT, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KR, LB, LK, LV, MA, MX, MY, NI, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SK, SV, TH, TN, TR, TW, UA, VE, VN, ZA |
| Quantity | 21,683 internal |
Product
Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory to the compatible monitor/defibrillator Switchless: M1741A, M1742A, M1743A, M1744A Switched: M4741A, M4742A, M4743A, M4744A - Product Usage: An electrical conductor 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
Internal Paddles may wear over time and may not be safe or ready for use, unless the directions in the Instructions for Use (IFU) to perform routine operational checks are followed. The instructions for use rely on these checks rather than specifying a maximum number of sterilization cycles to determine when the paddles should be discarded. A damaged Internal Paddle may not be able to deliver therapy.
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-2134-2020. 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.