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Siemens Medical Solutions USA, Inc recalls Luminos Agile Max (VE10, VF10, VF11)
Recalled May 31, 2023 · FDA recall Z-1479-2023 · 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. Siemens Healthineers became aware of one customer site where this issue was identified during clinical operation. · 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. Siemens Healthineers became aware of one customer site where this issue was identified during clinical operation.
Product
Luminos Agile Max (VE10, VF10, VF11)
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →