Philips Sterilizable Defibrillator Paddles recall
Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Numbers M4741A, M4742A, M4743A, M4744A - Product Usage: used in pairs to…
Why was Philips Sterilizable Defibrillator Paddles recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All units manufactured and distributed January 2015 to August 2020.
- Product
- Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Numbers M4741A, M4742A, M4743A, M4744A - Product Usage: used in pairs to…
- Recalling firm
- Philips North America, LLC
- Quantity
- 8,942
- Distribution
- Global Distribution. US Nationwide.
- Recall date
- November 4, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)