Recall Z-0078-2022 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips North America LLC
Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A
| Date | Oct 8, 2021 (initiated Feb 9, 2021) |
| Status | Open, Classified |
| Reason | Customers were not notified of previous recalls associated with various defibrillator models. |
| Root cause | Process control |
| Action | 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 tha |
| Quantity | 4 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051632 | PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A Philips Medical Systems, Oct 5, 2005 |