The Recall Desk

FDA (Devices) recall action 86985

Siemens Medical Solutions USA, Inc recalled 2 products on 2021-01-20

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2021-01-20
Critical
0
Units
287

Why these products were recalled

After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support arm becoming dislodged in cases when the monitor support arm is used intensely over a long period of time.

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.

1–2 of 2

  • HighFDA (Devices)··2021-01-20

    Siemens Uroskop Omnia Max X-ray System Recalled for Support Arm Risk

    Siemens is recalling 281 Uroskop Omnia Max X-ray systems because the monitor support arm may become dislodged after intense, long-term use.

    Product
    Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-01-20

    Siemens Uroskop Omnia X-ray System Recalled for Support Arm Risk

    Siemens is recalling six Uroskop Omnia X-ray systems because the monitor support arm may become dislodged after intense, long-term use.

    Product
    Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).
    Category
    Distribution
    0 states