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Recall Observatory FDA recall evidence

Device product

Luminos dRF Max- Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762471

Z-2526-2024

July 02, 2024

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 94948
Status
Ongoing
Classification
Class II
Quantity
24 units
Official record key
device-enforcement:Z-2526-2024

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: 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 pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays