The Recall Desk

FDA (Devices) recall action 71115

Siemens Medical Solutions USA, Inc recalled 4 products on 2015-06-03

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
2015-06-03
Critical
0
Units
532

Why these products were recalled

Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is sporadic in image recovery. Pressing undo button on the RAD subtask card or previous series button on the Image subtask card during image readout. Sporadically, during an automatic or a manual RIS update.

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.

1–4 of 4

  • ModerateFDA (Devices)··2015-06-03

    Siemens Luminos Agile Max Imaging System Software Recall

    Siemens is recalling 133 Luminos Agile Max imaging systems due to a software defect that causes image loss and connection issues.

    Product
    SIEMENS Luminos Agile Max; 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, angiography and pediatric examinations. Luminos Agile is a
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-06-03

    Siemens Axiom Luminos dRF Max Recall for Software Data Loss

    Siemens is recalling 133 Axiom Luminos dRF Max imaging systems due to a software defect that can cause acquired images to be deleted, requiring studies to be repeated.

    Product
    SIEMENS Axiom Luminos dRF Max, 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 pediatric examinations. The Axiom Luminos dRF is a device i
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-06-03

    Siemens Uroskop Omnia Max X-Ray System Software Data Loss Recall

    Siemens is recalling 133 Uroskop Omnia Max X-ray systems due to software defects that cause image deletion and connection issues.

    Product
    SIEMENS Uroskop Omnia Max ; 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 treatment table, may be used for
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-06-03

    Siemens Ysio Max Radiographic System Recalled for Software Data Loss

    Siemens is recalling 133 Ysio Max radiographic systems because a software defect can delete acquired images and studies, requiring patients to repeat exposures.

    Product
    SIEMENS Ysio Max; 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 bariatric patients. It c
    Category
    Distribution
    0 states