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

FDA device recall Z-0079-2022 · posted 2021-10-08 · Open, Classified

Recall details

Recalling firm

Philips North America LLC

Reason for recall

Customers were not notified of previous recalls associated with various defibrillator models.

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

MKJ

Quantity affected

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.

Date initiated

2021-02-09

Date posted

2021-10-08

Location

Bothell, WA