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Siemens Medical Solutions USA, Inc recalls Luminos dRF Max (VE10, VF10, VF11)
Recalled May 31, 2023 · FDA recall Z-1480-2023 · Siemens Medical Solutions USA
Hazard
Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube. · FDA Class II
Units
704 units in the United States (1945 units worldwide)
Sold at
US Nationwide - Worldwide Distribution
Description
Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube.
Product
Luminos dRF Max (VE10, VF10, VF11)
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →