FDA Enforcement
Class II
Ongoing
Multitom Rax -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 10860700
Recall: Z-2528-2024
·
Reported August 14, 2024
Enforcement
- Recall Number
- Z-2528-2024
- 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
Multitom Rax -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 10860700
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: N/A Serial Numbers: * Multitom Rax systems are licensed for sale in the US but have not been identified as being affected by this recall issue in the United States. However, this system is included in the event affected systems are identified in the future.
Distribution
US Nationwide distribution.
Quantity
0