Home / Recalls / Philips North America, LLC / Z-2134-2020

Z-2134-2020 Class II Terminated

Recalled by Philips North America, LLC — Andover, MA

Recall Details

Product Type
Devices
Report Date
June 3, 2020
Initiation Date
April 20, 2020
Termination Date
April 2, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
21,683 Internal Paddle Sets.

Product Description

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 Pattern

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, Switzerland Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam.

Code Information

All lots

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