FDA Enforcement
Class II
Ongoing
Luminos dRF Max- Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762471
Recall: Z-2526-2024
·
Reported August 14, 2024
Enforcement
- Recall Number
- Z-2526-2024
- 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 dRF Max- Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762471
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: Serial Numbers: Serial Number 8320 8198 8334 8474 8183 8322 8613 8244 8660 8436 8095 8371 8378 7805 5664 5615 8150 8130 8300 8093 8468 7791 8479 7136
Distribution
US Nationwide distribution.
Quantity
24 units