Z-0077-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 15, 2017
- Initiation Date
- October 4, 2017
- Termination Date
- October 15, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 devices
Product Description
RESONATE EL ICD VR, Model D432, Sterile.
Reason for Recall
The devices have an incorrect firmware configuration.
Distribution Pattern
The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.
Code Information
Serial numbers 224020, 224209, 224322, 224366, and 224506