—#181256

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.

FDA product code: MKJ — Automated External Defibrillators (Non-Wearable)
Device class: Class 3
Medical specialty: Cardiovascular
510(k) numbers: K021453
Affected lot / code info: All lots

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

Philips issued U.S. customer Field Safety Notification on 04/20/2020 via priority mail. Philips Markets Organizations are responsible for distributing the letters outside of the U.S.. Letter states reason for recall, health risk an action to take: Follow the Instructions for Use, Paddles Checks section. The Paddle Checks activities include; Mechanical Check, Visual Inspection, Functional Check, and Continuity Check. Perform these activities to confirm the paddles are safe and ready for use. Continue to perform the Paddles Checks activities as recommended in the IFU before use as this reduces the risk of a failure. If one or more of these Paddles Checks activities fail, you must remove them from service and replace the paddles. To acknowledge receipt of this notification, please complete and fax the Customer Reply Form to: +1.877.499.7223 or email to recall .response@philips.com. If you need further information or support concerning this notification, please AND SUPPORT contact your local Philips representative or call us at 1-800-722-9377

Recalling firm

Firm: Philips North America, LLC
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

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.

Timeline

Recall initiated: 2020-04-20
Terminated: 2021-04-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181256. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.