HeartStart MRx Monitor/Defibrillator recall
HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx is a lightweight, portable external defibrillator, offering…
Why was HeartStart MRx Monitor/Defibrillator recalled?
Non-conforming devices are identified, which may not have been included in prior field actions and may not have had a number of corrections applicable to these devices.
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?
Lot/ Serial # US00539461, US00539462
- Product
- HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx is a lightweight, portable external defibrillator, offering…
- Recalling firm
- Philips North America, LLC
- Quantity
- 2 units
- Distribution
- US Nationwide distribution in the state of MA.
- Recall date
- September 18, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)