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FDA-Device2014-10-08Class IIPROCESSING DEFECT

Siemens Ysio Max radiographic systems recalled for lost image and labeling errors

Siemens
OTHERNationwide distribution

Contact Siemens about your Ysio Max system

Siemens has identified a software malfunction in certain Ysio Max and related radiographic systems that can cause X-ray images to be lost during automatic updates and labels to display incorrectly. This means imaging exams may need to be repeated. The issue affects 10 systems with specific serial numbers across the U.S.

  • Check if your facility's Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, or Luminos Agile Max system is on the recall list by serial number
  • Contact Siemens Medical Solutions USA immediately if your system is affected
  • Do not perform new examinations until you receive guidance from Siemens
Hazard

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

Sold states
Nationwide Distribution - US including UT, MO, CO, MA, MN, MS, OH, SC, MI, and NY.
Affected count
10
Manufactured in
51 Valley Stream Pkwy, N/A, Malvern, PA, United States
Products
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 bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography. The Ysio Max uses integrated or portable digital detectors for generating diagnostic images by converting x-rays into electronic signals. Ysio Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0002-2015

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