Recalls / —

—#189140

Product

Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A

FDA product code

MKJ — Automated External Defibrillators (Non-Wearable)

Device class

Class 3

Medical specialty

Cardiovascular

510(k) numbers

K051632

Affected lot / code info

Model M3860A affected serial numbers: A09G-04198 and 510800626 Model M3861A affected serial numbers: A09H-00436 and A07J-03514

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm

Philips North America LLC

Address

22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2021-02-09

Posted by FDA

2021-10-08

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #189140. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.