Philips Recalls Sterilizable Defibrillator Paddles Due to Undetected Failure Mode
Philips is recalling 8,942 sterilizable defibrillator paddles because standard checks may miss a specific failure mode. An updated test procedure is available to detect the issue.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential failure mode that could result in harm, but no injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
Philips North America, LLC is recalling 8,942 units of Sterilizable Defibrillator Paddles, Switched Internal Paddles, including model numbers M4741A, M4742A, M4743A, and M4744A. These devices are used in pairs to transmit a controlled electrical shock directly to the exposed heart muscle of post-pubescent patients during cardiopulmonary surgery. The affected units were manufactured and distributed globally and in the US nationwide between January 2015 and August 2020.
The recall is issued because the periodic Paddle Checks recommended in the Instructions for Use (IFU) may not detect one specific failure mode for the Switched Internal Defibrillator Paddles. Philips has created an addendum to the IFU that includes a specific test for the switched paddles, which will detect this failure mode.
Healthcare facilities and users should stop using the affected paddles and consult the Philips addendum for the updated testing procedure to ensure the devices are functioning correctly before use.
The recalled product
- Product
- 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…
- Manufacturer
- Philips North America, LLC
- Hazard
- Affected units
- 8,942
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All units manufactured and distributed January 2015 to August 2020.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Philips North America, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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