Philips Recalls Sterilizable Defibrillator Internal Paddles Due to Wear Risk
Philips is recalling 21,683 sets of sterilizable defibrillator internal paddles because they may wear over time and fail to deliver therapy if routine checks are not performed.
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 defect (wear) could prevent the delivery of life-saving therapy, but the source text does not report any specific injuries, illnesses, or fatalities, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Philips North America, LLC is recalling 21,683 sets of Sterilizable Defibrillator Internal Paddles. These paddles are accessories used with specific Philips monitor/defibrillators (M1741A-M1744A and M4741A-M4744A) to transmit electrical shocks directly to the heart during cardiopulmonary surgery. The recall covers all lots and includes units distributed worldwide, including the United States and numerous international markets.
The recall is issued because the internal paddles may wear over time and may not be safe or ready for use unless routine operational checks are performed as described in the Instructions for Use (IFU). The IFU relies on these operational checks rather than specifying a maximum number of sterilization cycles to determine when the paddles should be discarded. A damaged internal paddle may not be able to deliver therapy.
Healthcare facilities and users should stop using the affected internal paddles and contact Philips for further instructions on replacement or repair. Users should ensure that any remaining paddles are subjected to the routine operational checks specified in the IFU to verify their safety and readiness for use.
The recalled product
- Product
- Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory to the compatible monitor/defibrillator Switchless: M1741A, M1742A, M1743A, M1744A Switched: M4741A, M4742A, M4743A, M4744A - Product Usage: An electrical conductor used in pairs to…
- Manufacturer
- Philips North America, LLC
- Hazard
- Affected units
- 21,683
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 lots
Distribution
Distributed nationwide across the United States.
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