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Siemens Medical Solutions USA, Inc recalls Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. The Ysio Max is a
Recalled January 28, 2015 · FDA recall Z-0994-2015 · Siemens Medical Solutions USA
Hazard
Potential for composed images to be flipped before being sent to PACS on systems with software version VE10 and SmartOrtho license. Flipped images may be reversed so the associated annotations, e.g. labels (R/L), may be displayed incorrectly, potentially leading to misdiagnosis. · FDA Class II
Units
11
Sold at
US Distribution to states of: ID, IL, MI, MN, MO, ND and PA.
Description
Potential for composed images to be flipped before being sent to PACS on systems with software version VE10 and SmartOrtho license. Flipped images may be reversed so the associated annotations, e.g. labels (R/L), may be displayed incorrectly, potentially leading to misdiagnosis.
Product
Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license. 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.
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →