Recall Z-0285-2021— Philips North America, LLC

Name: FDA recall Z-0285-2021
Creator: U.S. Food and Drug Administration
Published: 2020-09-14

Class II · Terminated

Class II FDA medical device recall by Philips North America, LLC, initiated 2020-09-14, terminated 2022-09-13. It names one FDA 510(k) clearance: K031187. 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.. Reason: 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..

Recalling firm: Philips North America, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-09-14
Terminated: 2022-09-13
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K031187 — HEARTSTART MRX, MODEL M3535APhilips Medical Systems·cleared 2003-08-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.