The Recall Desk

FDA (Devices) recall action 91649

Siemens Medical Solutions USA, Inc recalled 5 products on 2023-03-01

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2023-03-01
Critical
0
Units
—

Why these products were recalled

Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values

The agency’s own wording, quoted from the enforcement report.

1–5 of 5

  • HighFDA (Devices)··2023-03-01

    Diagnostic imaging system recalled for collision risk from default settings

    Siemens Luminos dRF Max diagnostic imaging systems are being recalled due to a risk of collision with ceiling, walls, or nearby objects caused by default room configuration settings. This could result in serious injury to staff or patients.

    Product
    Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762471
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-03-01

    Diagnostic imaging system recalled for collision risk from default settings

    Siemens Luminos Agile Max diagnostic imaging systems recalled due to default configuration parameters allowing collision with room structures, risking serious injury to staff or patients.

    Product
    Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10762472
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-03-01

    Diagnostic imaging system recalled due to ceiling and wall collision risk

    Siemens Uroskop Omnia Max imaging systems are recalled due to collision risk with ceilings, walls, or objects caused by default configuration settings. The systems may move dangerously, potentially injuring staff or patients.

    Product
    Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762473
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-03-01

    Luminos Agile Diagnostic Imaging System Collision Risk Recall

    Siemens recalls Luminos Agile imaging systems that may collide with ceilings or walls due to default configuration settings, potentially causing serious injury to staff or patients.

    Product
    Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number: 10502200
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-03-01

    Diagnostic Imaging System Recalled for Potential Ceiling and Wall Collision Risk

    Siemens Luminos dRF diagnostic imaging system is being recalled nationwide due to potential collision with ceilings, walls, or objects caused by default room configuration parameters. Collisions could result in serious injury to patients or staff.

    Product
    Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10094200
    Category
    Distribution
    0 states