Z-2134-2020Class II

Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory to the compatible...

Name: Z-2134-2020 Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory to the compatible...
Creator: Philips North America, LLC
Published: 2020-04-20
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2020-04-20 / Terminated / root cause: design

FDA source

Philips North America, LLC began a recall of Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory to the compatible monitor/defibrillator Switchless: M1741A, M1742A... on 2020-04-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2134-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-20
Posted: 2020-05-27
Terminated: 2021-04-02
Recalling firm: Philips North America LLC
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.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
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.
Root cause tag: design
FDA 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 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 [email protected]. 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.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2134-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2134-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-27

Product code MKJ

K021453Class IIIHeartstream Xl Defibrillator/monitor, Model #M4735aPhilips Medical Systems / cleared 2002-07-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)