—#199944

Product

Luminos Agile Max (VE10, VF10, VF11)

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K173639
Affected lot / code info: Model: 10762472

Why it was recalled

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.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

Siemens Medical Solutions USA, Inc., will provide software updates to the affected systems with software versions VF10 and VF11 with software via Update Instructions (UI) XP007/23/S, XP004/23/S, XP003/23/S, and XP001/23/S

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: US Nationwide - Worldwide Distribution

Timeline

Recall initiated: 2022-11-23
Posted by FDA: 2023-05-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #199944. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.