Philips North America LLC Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304
Brand
Philips North America LLC
Lot Codes / Batch Numbers
Model 861304 serial number: 0805164058, B12C-03067, B07I-01107, B09D-01464, B08L-00595, B10I-03918
Products Sold
Model 861304 serial number: 0805164058, B12C-03067, B07I-01107, B09D-01464, B08L-00595, B10I-03918
Philips North America LLC is recalling Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304 due to Customers were not notified of previous recalls associated with various defibrillator models.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Customers were not notified of previous recalls associated with various defibrillator models.
Recommended Action
Per FDA guidance
On February 11, 2021, Philips issued a "Urgent - Safety Notification" to affected consignees via certified Mail. In addition to notifying consignees that may have been omitted from notification of one or more recalls, Philips asked affected consignees to take 1. To acknowledge receipt of this notification, please complete and return the Customer Reply Form by email or by fax by February 15, 2021. Email to: ECR.Recall.Response@Philips.com Or, Fax: 1 (833) 371-1011 2. A Philips representative will reach out to you to help you identify any affected AED. 3. After it has been confirmed that you have an affected AED and a replacement Philips AED has been sent to you, please return the affected AED to Philips using the shipping label to be provided. 4. The affected AED may remain in service until you receive a replacement Philips AED. 5. Philips will exchange affected devices with a replacement Philips AED free of charge. 6. If you need any further information or support concerning this issue, please contact Philips at 1 (800) 263-3342. 7. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s Med Watch Adverse Event Reporting program either online, by regular mail or by fax.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CT, FL, GA, IN, MI, MO, NJ, NY, OH, TX, WA
Page updated: Jan 10, 2026