The Recall Desk

FDA (Devices) recall action 75126

Siemens Medical Solutions USA, Inc recalled 3 products on 2016-10-12

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
2016-10-12
Critical
0
Units
111

Why these products were recalled

Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion systems. There is an unlikely risk that an internal part of the table may detach causing the table top to tilt to the left side which could result in an injury to a patient on the table.

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)··2016-10-12

    Siemens Recalls Ysio Max Radiographic Systems Due to Table Tilt Risk

    Siemens is recalling 37 Ysio Max radiographic systems because a table part may detach, causing the table to tilt and potentially injure patients.

    Product
    YSIO Max Product Usage: 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 an
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2016-10-12

    Siemens Recalls Multix Fusion X-Ray Systems Due to Table Tilt Risk

    Siemens is recalling 37 Multix Fusion X-ray systems because an internal table part may detach, causing the table to tilt and potentially injure patients.

    Product
    Multix Fusion Stationary X-Ray System Product Usage: The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen and extremities and may be
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2016-10-12

    Siemens Recalls Multix Fusion VA10 Radiographic Systems Due to Table Defect

    Siemens is recalling 37 Multix Fusion VA10 radiographic systems because a table part may detach, causing the table to tilt and potentially injure patients.

    Product
    Multix Fusion VA10 Product Usage: The Multix Fusion VA10 system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including:skull, chest, abdomen and extremities and may be used on pediat
    Category
    Distribution
    0 states