The Recall Desk

FDA (Devices) recall action 69258

Siemens Medical Solutions USA, Inc recalled 4 products on 2014-10-08

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2014-10-08
Critical
0
Units
18

Why these products were recalled

Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of serial numbers that will cause lost images due to an automatic Radiology Information System (RIS) worklist update, thus causing examinations to be repeated. Image label may also be displayed incorrectly after images

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.

States named across these recalls

1–4 of 4

  • HighFDA (Devices)··2014-10-08

    Siemens Ysio Max Radiographic Systems Recalled for Image Loss Risk

    Siemens is recalling Ysio Max radiographic systems because a malfunction can cause images to be lost, requiring patients to repeat examinations.

    Product
    Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and…
    Category
    Distribution
    10 states
  • HighFDA (Devices)··2014-10-08

    Siemens AXIOM Luminos dRF Max Systems Recalled for Image Loss Risk

    Siemens is recalling AXIOM Luminos dRF Max systems due to malfunctions that cause lost images and incorrect labels, potentially leading to repeated examinations.

    Product
    Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and…
    Category
    Distribution
    10 states
  • HighFDA (Devices)··2014-10-08

    Siemens Uroskop Omnia Max X-Ray System Recalled for Image Loss

    Siemens is recalling two Uroskop Omnia Max systems because a malfunction causes image loss and incorrect labels, leading to repeated examinations.

    Product
    Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The system,, which includes a radiologic/urologic…
    Category
    Distribution
    10 states
  • HighFDA (Devices)··2014-10-08

    Siemens Medical Imaging Systems Recalled for Image Loss and Labeling Errors

    Siemens is recalling five Luminos Agile Max systems due to malfunctions that cause image loss and incorrect labels, leading to repeated examinations.

    Product
    Siemens Luminos Agile Max system The Luminos Agile is intended to be used as a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F…
    Category
    Distribution
    10 states