Recall Z-2134-2020 · MKJ Automated External Defibrillators (Non-Wearable)
Philips North America, LLC
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 p
| Date | Apr 20, 2020 |
| Status | Terminated |
| Reason | 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 | Device Design |
| Action | 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 t |
| Quantity | 21,683 Internal Paddle Sets. |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021453 | HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A Philips Medical Systems, Jul 3, 2002 |