Device product
RESONATE X4 CRT-D, Model G447, Sterile.
Z-0081-2018
Product summary
- Event
- Event 78323
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11 devices
- Official record key
device-enforcement:Z-0081-2018
Official wording
Reason: The devices have an incorrect firmware configuration.
Code information: Serial numbers 174030, 174900, 174995, 175178, 175328, 175329, 175396, 175440, 175503, 175545, and 175606
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