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U.S. Department of Health and Human Services

Class 2 Device Recall Philips, HeartStart FR2 Defibrillator

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  Class 2 Device Recall Philips, HeartStart FR2 Defibrillator see related information
Date Initiated by Firm February 09, 2021
Date Posted October 08, 2021
Recall Status1 Open3, Classified
Recall Number Z-0078-2022
Recall Event ID 88637
510(K)Number K051632  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A
Code Information Model M3860A affected serial numbers: A09G-04198 and 510800626 Model M3861A affected serial numbers: A09H-00436 and A07J-03514
Recalling Firm/
Manufacturer		 Philips North America LLC
22100 Bothell Everett Hwy
Bothell WA 98021-8431
For Additional Information Contact Customer Services
1800-722-9377
Manufacturer Reason
for Recall		 Customers were not notified of previous recalls associated with various defibrillator models.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS
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