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Siemens Medical Solutions USA, Inc Recall 92229

Description: Luminos Agile Max (VE10, VF10, VF11)

Siemens Medical Solutions USA, Inc Recall 92229 Information

Mandated?FDA Mandated
Recall NumberZ-1479-2023
Event ID92229
Event DescriptionLuminos Agile Max (VE10, VF10, VF11)
Product TypeDevices
DistributionUS Nationwide - Worldwide Distribution
Quantity704 units in the United States (1945 units worldwide)
Recall ReasonUnder 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.
Device Classification20230531
Device Code InfoModel: 10762472
Center Classification Date20230523
Recall Initiation Date20221123
Recalling FirmSiemens Medical Solutions USA, Inc
Initial Notification Letter
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