The Recall Desk

FDA (Devices) recall action 84815

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
1,028

Why these products were recalled

A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.

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 Software Bug Affecting Patient Images

    Siemens Medical Solutions USA, Inc. is recalling 46 Luminos dRF Max digital radiography systems due to a software bug that may assign one image to two different patients, potentially affecting medical diagnosis.

    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…
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    0 states
  • HighFDA (Devices)··2020-02-26

    Siemens Luminos Agile Max Recalled for Software Bug Affecting Patient Images

    Siemens is recalling 475 Luminos Agile Max devices due to a software bug that may assign one image to two patients, potentially affecting diagnosis.

    Product
    Luminos Agile Max, model no. 10762471 - 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…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-02-26

    Siemens Ysio Max Radiographic System Recalled for Software Bug

    Siemens Medical Solutions is recalling 507 Ysio Max radiographic systems because a software bug may assign one image to two different patients, potentially affecting medical diagnosis.

    Product
    Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures f the whole body including: skull, chest, abdomen, and extremities and may be used on…
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    Distribution
    0 states