FDA-Device2023-05-31Class II
Luminos Agile Max (VE10, VF10, VF11)
Siemens Medical Solutions USA, Inc
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.
Sold states
US Nationwide - Worldwide Distribution
Affected count
704 units in the United States (1945 units worldwide)
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Luminos Agile Max (VE10, VF10, VF11)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1479-2023Don't want to check this manually?
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