FDAClass IIOctober 20, 2021

Philips recall

Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304

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 861304 serial number: 0805164058, B12C-03067, B07I-01107, B09D-01464, B08L-00595, B10I-03918

Product
Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304
Recalling firm
Philips North America LLC
Quantity
6 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)
Open FDA enforcement record Latest recalls