FDA Enforcement
Class II
Ongoing
LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 11574100
Recall: Z-2527-2024
·
Reported August 14, 2024
Enforcement
- Recall Number
- Z-2527-2024
- Event ID
- 94948
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Siemens Medical Solutions USA, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 14, 2024
- Initiation Date
- July 2, 2024
- Classification Date
- August 7, 2024
- Address
- 40 Liberty Blvd, Malvern, PA, 19355-1418, United States
Description
LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 11574100
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 Info
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
US Nationwide distribution.
Quantity
26 units