| Class 2 Device Recall Philips Sterilizable Defibrillator Internal Paddles | |
Date Initiated by Firm | April 20, 2020 |
Create Date | May 27, 2020 |
Recall Status1 |
Terminated 3 on April 02, 2021 |
Recall Number | Z-2134-2020 |
Recall Event ID |
85571 |
510(K)Number | K021453 |
Product Classification |
Automated external defibrillators (non-wearable) - Product Code MKJ
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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. |
Code Information |
All lots |
Recalling Firm/ Manufacturer |
Philips North America, LLC 3000 Minuteman Rd Andover MA 01810-1032
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For Additional Information Contact | Philips Customer Services 800-722-9377 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 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 |
Quantity in Commerce | 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 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = MKJ
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