Z-0285-2021Class II

Philips Sterilizable Defibrillator Paddles, Switchless Internal Paddles, Model Numbers M1741A, M1742A...

Name: Z-0285-2021 Philips Sterilizable Defibrillator Paddles, Switchless Internal Paddles, Model Numbers M1741A, M1742A...
Creator: Philips North America, LLC
Published: 2020-09-14
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2020-09-14 / Terminated / root cause: design

FDA source

Philips North America, LLC began a recall of Philips Sterilizable Defibrillator Paddles, Switchless Internal Paddles, Model Numbers M1741A, M1742A, M1743A, M1744A - Product Usage: used in pairs to... on 2020-09-14. FDA classified it as Class II and gives the reason as "The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator Paddles may not detect one failure mode for the Switched Internal Defibrillator Paddles. Philips has created an addendum...". 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-0285-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-14
Posted: 2020-10-23
Terminated: 2022-09-13
Recalling firm: Philips North America LLC
Product: Philips Sterilizable Defibrillator Paddles, Switchless Internal Paddles, Model Numbers M1741A, M1742A, M1743A, M1744A - Product Usage: 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: The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator Paddles may not detect one failure mode for the Switched Internal Defibrillator Paddles. Philips has created an addendum to the IFU, that includes a test for the switched paddles only, which will detect this failure mode.
Root cause tag: design
FDA root cause: Device Design
Action: Urgent Medical Device Correction notification letters dated 9/4/20 were sent to customers. Insert a copy of the attached Instructions for Use Addendum: Sterilizable Defibrillator Paddles: Insulation Resistance Check for Switched Internal Paddles to the Sterilizable Defibrillator Paddles IFU. Follow the Instructions for Use, Paddles Checks section. The Paddle Checks activities include: Mechanical Check, Visual Inspection, Functional Check, Continuity Check, and Insulation Resistance Check. Perform these activities to confirm the paddles are safe and ready for use. The Insulation Resistance Test is to be applied only to Switched Internal Paddles (M4741A, M4742A, M4743A, and M4744A). Continue to perform the Paddles Checks activities as recommended in the IFU, before use as this reduces the risk of a failure as the paddles age. If your Internal Paddles fail any of these Paddle Checks, the IFU directs that the paddles should be removed from service and replaced. To acknowledge receipt of this notification, please complete and fax the Customer Reply Form to: +1.877.499.7223 or email to [email protected]. If you need further information or support concerning this notification, please contact your local Philips representative or call us at 1-800-722-9377. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs Med Watch Adverse Event Reporting program either online, by regular mail or by fax.
Quantity in commerce: 2,202
Distribution: Global Distribution. US Nationwide.
Product codes and lots: All units manufactured and distributed January 2015 to August 2020.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0285-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0284-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-04	2020-10-23
Z-0285-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-04	2020-10-23

Product code MKJ

K031187Class IIIHeartstart Mrx, Model M3535aPhilips Medical Systems / cleared 2003-08-27

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)