Device product
RESONATE EL ICD DR, Model D433, Sterile.
Z-0078-2018
Product summary
- Event
- Event 78323
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 devices
- Official record key
device-enforcement:Z-0078-2018
Official wording
Reason: The devices have an incorrect firmware configuration.
Code information: Serial numbers 530802, 531123, 531237, 531292, 531301, 531446, 531492, 531520, 531536, 531539, 531545, and 531767.
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