Device product
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Z-1740-2025
Product summary
- Event
- Event 96377
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 996 units (267 US, 729 OUS)
- Official record key
device-enforcement:Z-1740-2025
Official wording
Reason: An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.
Code information: Model Number: 830089; Software Versions: 6x, 7.x, and 8.x; UDI-DIs: (01)00884838106970(11)211130(10)6.1.0.0 (Version 6.1.0.0), (01)00884838106970(11)220623(10)6.2.0.0 (Version 6.2.0.0), (01)00884838115378(11)221214(10)7.0.0.0 (Version 7.0.0.0), (01)00884838115378(11)230711(10)7.1.0.0 (Version 7.1.0.0), (01)00884838122000(11)240325(10)8.0.0.0 (Version 8.0.0.0).
Distribution pattern: Domestic: Nationwide Distribution International: Australia, Austria, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Indonesia, Ireland, Italy, Japan, Luxembourg, Mexico, Netherlands, Norway, Poland, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom.
Derived failure modes
-
Device software or design
software when using the Echo Module of ISCV, the issue