Philips recall
Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A
Why was Philips recalled?
Customers were not notified of previous recalls associated with various defibrillator models.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
Model M3860A affected serial numbers: A09G-04198 and 510800626 Model M3861A affected serial numbers: A09H-00436 and A07J-03514
- Product
- Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A
- Recalling firm
- Philips North America LLC
- Quantity
- 4 units
- Distribution
- U.S.: CA, CT, FL, GA, IN, MI, MO, NJ, NY, OH, TX, and WA. International distribution in the countries of Australia, Canada, France, Germany, Japan, Norway, Switzerland.
- Recall date
- October 20, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)