The Recall Desk

FDA (Devices) recall action 82211

Siemens Medical Solutions USA, Inc recalled 2 products on 2019-03-13

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
2019-03-13
Critical
0
Units
197

Why these products were recalled

The swivel arm holding the monitors may become dislodged from the carrying arm.

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)··2019-03-13

    Siemens Uroskop Omnia Max Fluoroscopic X-ray System Recall for Swivel Arm Defect

    Siemens is recalling 191 Uroskop Omnia Max fluoroscopic X-ray systems because the swivel arm holding the monitors may become dislodged from the carrying arm.

    Product
    Uroskop Omnia Max -fluoroscopic X-ray system Model # 10762473 Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-03-13

    Siemens Uroskop Omnia Fluoroscopic X-ray System Recalled for Monitor Arm Defect

    Siemens is recalling six Uroskop Omnia fluoroscopic X-ray systems because the swivel arm holding the monitors may become dislodged from the carrying arm.

    Product
    Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop Omnia is 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