# FDA recall Z-2134-2020

> **Philips North  America, LLC** · Class II · device recall initiated 2020-04-20.

## 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.

## Distribution

Worldwide distribution - US Nationwide distrubtion and the countries of Albania, Argentina, Australia, Austria, Bahrain,   Bangladesh, Belgium, Bolivia, Botswana, Brazil, Bulgaria,   Cambodia, Canada, Chile, China, Colombia, Congo (Democratic Republic of the), Costa Rica, C¿te D'Ivoire, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt  El Salvador, Estonia, Finland, France, Gabon, Georgia, Germany, Greece, Guatemala, Haiti, Hong Kong, Hungary,   India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan,   Jordan, Kazakhstan, Kenya, Korea, Republic of Lao People's , Democratic Republic Latvia, Lebanon, Libya, Macao,   Macedonia, Malaysia, Maldives, Mauritius, Mexico, Montenegro, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman  Pakistan, Palestine, State of Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania  Russian Federation, Saudi Arabia, Serbia, Singapore  Slovakia, South Africa, Spain, Sri Lanka, Sweden,

## Key facts

- **Recall number:** Z-2134-2020
- **Recalling firm:** Philips North  America, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-20
- **Report date:** 2020-06-03
- **Termination date:** 2021-04-02

- **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-2134-2020

## Citation

> AI Analytics. FDA recall Z-2134-2020. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-2134-2020. Source: US FDA. Licensed CC0.

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