Philips HeartStart XL Defibrillator/Monitor recall
Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital by qualified medical personnel trained…
Why was Philips HeartStart XL Defibrillator/Monitor recalled?
The rotary therapy selector switch may fail, resulting in unexpected device behavior including: 1) The device may not turn on; 2) The device may not perform the selected function;3) The device may deliver a shock with an energy level different than the setting selected by the user. In any of these scenarios, appropriate therapy delivery may be delayed.
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. Product has been discontinued.
- Product
- Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital by qualified medical personnel trained…
- Recalling firm
- Philips North America, LLC
- Quantity
- 94,034 units
- Distribution
- Worldwide distribution - US Nationwide distribution.
- Recall date
- May 27, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)