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Recall Observatory FDA recall evidence

Device 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.

Z-0285-2021

September 14, 2020

Class II

Product summary

Firm
Philips North America, LLC
Event
Event 86441
Status
Terminated
Classification
Class II
Quantity
2,202
Official record key
device-enforcement:Z-0285-2021

Official wording

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.

Code information: All units manufactured and distributed January 2015 to August 2020.

Distribution pattern: Global Distribution. US Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.