Reported Jun 3, 2020 · Terminated
Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory to the compatible…
Philips North America, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America, LLC · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory to the compatible
- monitor/defibrillator Switchless
M1741AM1742AM1743A
- M1744A Switched
M4741AM4742AM4743A
- M4744A - Product UsageAn electrical conductor 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
- Lot codes and dates
- All lots
- Amount recalled
- 21,683 Internal Paddle Sets.
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Internal Paddles may wear over time and may not be safe or ready for use, unless the directions in the Instructions for Use (IFU) to perform routine operational checks are followed. The instructions for use rely on these 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Philips North America, LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.