Device product
LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 11574100
Z-2527-2024
Product summary
- Event
- Event 94948
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 26 units
- Official record key
device-enforcement:Z-2527-2024
Official wording
Reason: The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
Code information: UDI: (01)04056869269931(21) Serial Numbers: Serial Number 10251 10181 10278 10274 10115 10309 10024 10140 10073 10327 10091 10307 10253 10117 10311 10030 10194 10029 10063 10076 10173 10172 10170 10079 10234 10330
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays