Device product
RESONATE EL ICD VR, Model D432, Sterile.
Z-0077-2018
Product summary
- Event
- Event 78323
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 devices
- Official record key
device-enforcement:Z-0077-2018
Official wording
Reason: The devices have an incorrect firmware configuration.
Code information: Serial numbers 224020, 224209, 224322, 224366, and 224506
Distribution pattern: The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.
Derived failure modes
-
Device software or design
incorrect firmware