Device product
MOMENTUM X4 CRT-D, Model G138, Sterile.
Z-0080-2018
Product summary
- Event
- Event 78323
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 devices
- Official record key
device-enforcement:Z-0080-2018
Official wording
Reason: The devices have an incorrect firmware configuration.
Code information: Serial numbers 377292, 377337, 377341, and 377347
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