Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation
Reported: June 3, 2020 Initiated: April 21, 2020 #Z-2137-2020
Product Description
Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation
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
- 130 units (US 126; OUS 4)
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of KY, MA, ND, NY and the countries of United Kingdom, Bahrain.
- Location
- Andover, MA
Frequently Asked Questions
What product was recalled? ▼
Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation. Recalled by Philips North America, LLC. Units affected: 130 units (US 126; OUS 4).
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-2137-2020.
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