Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A
- Company
- Philips North America Llc
- Recall Initiated
- February 9, 2021
- Posted
- October 8, 2021
- Recall Number
- Z-0078-2022
- Quantity
- 4 units
- Firm Location
- Bothell, WA
Reason for Recall
Customers were not notified of previous recalls associated with various defibrillator models.
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.
Lot / Code Info
Model M3860A affected serial numbers: A09G-04198 and 510800626 Model M3861A affected serial numbers: A09H-00436 and A07J-03514
Root Cause
Process control
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.