FDAFDA · Food and drugs·Recall number Z-0284-2021
Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Numbers M4741A, M4742A, M4743A, M4744A - 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.
Published November 4, 2020 · Recall initiated: September 14, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips North America, LLC
- Distributor
- Global Distribution. US Nationwide.
- Lot
- All units manufactured and distributed January 2015 to August 2020.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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