Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of ventricular tachycardia and ventricular fibrillation.
Reported: June 3, 2020 Initiated: April 27, 2020 #Z-2157-2020
Product Description
Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of ventricular tachycardia and ventricular fibrillation.
Reason for Recall
HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections
Details
- Recalling Firm
- Philips North America, LLC
- Units Affected
- 260 units
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of China, Republic of Korea, Netherlands, Norway, United Kingdom.
- Location
- Andover, MA
Frequently Asked Questions
What product was recalled? ▼
Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of ventricular tachycardia and ventricular fibrillation.. Recalled by Philips North America, LLC. Units affected: 260 units.
Why was this product recalled? ▼
HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 3, 2020. Severity: Moderate. Recall number: Z-2157-2020.
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