Device product
MAMMOMAT Inspiration;
Z-0878-2026
Product summary
- Event
- Event 97920
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6 units (3 US, 3 OUS)
- Official record key
device-enforcement:Z-0878-2026
Official wording
Reason: There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
Code information: Model Number: 10140000; UDI-DI: 04056869009063; System Serial Numbers: 6734, 6694, 10121, 10309, 10336, 10342;
Distribution pattern: Worldwide - US Nationwide distribution in the states of AR, CA, NY and the countries of Australia, Canada, India.
Derived failure modes
-
Unknown
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.