Z-0489-2018 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 14, 2018
- Initiation Date
- July 12, 2017
- Termination Date
- May 27, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 71 units
Product Description
MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
Reason for Recall
Affected units may have a defective component that is intended to protect the internal circuitry from high voltages during shock delivery. The defective component may also prevent delivery of shocks in AED mode.
Distribution Pattern
No U.S. distribution, Internationally to: India, Ireland, Japan, Republic of Korea, Malaysia, Mexico, South Africa & United Kingdom
Code Information
Serial Numbers: US00601802, US00601968, US00601969, US00602114, US00602122, US00602124, US00602125, US00602126, US00602127, US00602128, US00602145, US00602180, US00602182, US00602184, US00602185, US00602186, US00602187, US00602189, US00602206, US00602236, US00602237, US00602238, US00602239, US00602240, US00602241, US00602242, US00602243, US00602244, US00602245, US00602246, US00602247, US00602248, US00602250, US00602251, US00602252, US00602253, US00602254, US00602344, US00602345, US00602346, US00602347, US00602348, US00602349, US00602350, US00602351, US00602352, US00602353, US00602354, US00602355, US00602356, US00602357, US00602358, US00602359, US00602360, US00602361, US00602362, US00602363, US00602364, US00602365, US00602366, US00602367, US00602368, US00602369, US00602370, US00602371, US00602372, US00602373, US00602374, US00602375, US00602376, US00602377