The Recall Desk

FDA (Devices) recall action 84813

Siemens Medical Solutions USA, Inc recalled 3 products on 2020-02-26

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2020-02-26
Critical
0
Units
713

Why these products were recalled

Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or persons when the operator uses the override function.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • HighFDA (Devices)··2020-02-26

    Siemens Luminos dRF Max Recalled for Collision Control Override Risk

    Siemens is recalling 46 Luminos dRF Max devices because an override function can disable collision controls, creating a risk of collision with obstacles or persons.

    Product
    Luminos dRF Max, Model No. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, t
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2020-02-26

    Siemens Uroskop Omnia max Recalled for Collision Control Override Risk

    Siemens is recalling 192 Uroskop Omnia max devices because a bypass key can override collision controls, creating a risk of collision with obstacles or persons.

    Product
    Uroskop Omnia max, Model No. 10762473 - Product Usage: Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system is designed primarily for urological diagnosis and the support of urological therapeutic
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-02-26

    Siemens Luminos Agile Max X-ray System Recalled for Collision Risk

    Siemens is recalling 475 Luminos Agile Max X-ray systems because a bypass key can override collision controls, creating a risk of collision with obstacles or persons.

    Product
    Luminos Agile Max, Model No. 10762472 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeleta
    Category
    Distribution
    0 states