Philips Recalls Sterilizable Defibrillator Paddles Due to Undetected Failure Mode
Philips is recalling 2,202 sterilizable defibrillator paddles because standard periodic checks may fail to detect a specific failure mode in switchless internal models.
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 high-risk medical device where a failure mode may not be detected by standard checks, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Philips North America, LLC is recalling 2,202 units of Sterilizable Defibrillator Paddles, specifically the Switchless Internal Paddles (Model Numbers M1741A, M1742A, M1743A, and M1744A). These medical 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 being issued because the periodic Paddle Checks recommended in the Instructions for Use (IFU) may not detect one specific failure mode associated with the Switched Internal Defibrillator Paddles. To address this, Philips has created an addendum to the IFU that includes a specific test for the switched paddles, which is designed to detect this failure mode.
Healthcare facilities and users of these devices should review the updated Instructions for Use addendum provided by Philips to ensure the appropriate testing procedures are followed to detect the identified failure mode.
The recalled product
- 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…
- Manufacturer
- Philips North America, LLC
- Hazard
- Affected units
- 2,202
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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