The Recall Desk
HighFDA (Devices)·Z-2525-2024·Announced 2024-08-14

Siemens x-ray display system support arm may lower unexpectedly

Siemens Luminos Agile Max x-ray imaging systems have a support arm that may unintentionally lower during display positioning, creating an injury risk.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm product (structural mechanical failure in medical equipment) where no injuries have been reported, meeting the score 3 criterion per the rubric: 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling the Luminos Agile Max x-ray imaging system (Model 10762472). The support arm may unintentionally lower during display positioning, creating a risk of injury to persons positioned beneath the ceiling or wall-mounted display.

Approximately 333 units have been distributed nationwide across the United States. Specific serial numbers are identified in the FDA recall notice.

The recalled product

Product
Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762472
Manufacturer
Siemens Medical Solutions USA, Inc
Hazard
  • mechanical-failure
  • impact-injury

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI: (01)04056869009162(21) Serial Numbers

Distribution

Distributed nationwide across the United States.