Medical Device Recall: Z-0078-2022

FDA Recalls dataset · Firm: Philips North America LLC · Status: Open, Classified

Recall Action Class: N/A Date Initiated: 2021-02-09 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0078-2022.

Recall Res Number
Z-0078-2022
Recalling Firm / Manufacturer
Philips North America LLC
FEI Number
1000524572
Recall Status
Open, Classified
Recall Classification
N/A
Date Initiated
2021-02-09
Date Posted
2021-10-08
Date Terminated
N/A
Product Code
MKJ
Event Number
88637
Product Quantity
4 units
Product Description Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A
Reason for Recall Customers were not notified of previous recalls associated with various defibrillator models.
Action Details 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.
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.
Code Information / Serial Numbers Model M3860A affected serial numbers: A09G-04198 and 510800626 Model M3861A affected serial numbers: A09H-00436 and A07J-03514

Related Establishments / Registrations

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