Recall Z-0175-2019 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips Electronics North America Corp.
Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardia (VTs). Both models are used with disposable pads applied to potential victims of SCA with the following symptoms: 1) Unresponsiveness 2) Absence o
| Date | Oct 10, 2018 |
| Status | Terminated |
| Reason | Automated external defibrillators may not fully meet IPx5 water ingress specification. The device may fail to function should water intrusion occur. |
| Root cause | Device Design |
| Action | On 10/10/2018, Urgent Medical Device Recall notices, which include Field Safety Notices, were mailed via certified mail to U.S. customers. The recalling firm's Key Markets are responsible for distributing the letters outside of the U.S. Firm is asking customers to follow the Action to be Taken by Customer/User section of the Medical Device Correction Notification/Field Safety Notice: 1) Identify the AEDs affected by this Field Safety Notice by checking the serial numbers. 2) You may continue to use your present device until a replacement AED is provided from the firm if you take precautions t |
| Quantity | 432 |
| Distribution | Worldwide Distribution - U.S Nationwide in the states of: GA, MO, IN, FL, NY, HI, CA, LA, WA, IL, NE; Foreign (OUS):Australia, Austria,Belgium, Canada, France, Germany, Hong Kong, Italy, Japan, Kazakhstan, Netherlands, Norway, Spain, Switzerland, Taiwan, United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.