Is Luminos Agile Max (VE10, VF10, VF11) recalled?

Recall reasons: • 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. • 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. Status: FDA Mandated Initial Firm Notification: Letter Distribution: US Nationwide - Worldwide Distribution

Medium RiskFDA Device

Siemens Medical Solutions USA, Inc: 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 dur

Agency Publication Date: May 23, 2023

Affected Products

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

Model: 10762472

Product: Luminos dRF Max (VE10, VF10, VF11)

Model: 10762471

Product: LUMINOS Lotus Max (VF11)

Model: 11574100

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92229

Status: Active

Manufacturer: Siemens Medical Solutions USA, Inc

Manufactured In: United States

Units Affected: 3 products (704 units in the United States (1945 units worldwide))

Agency Last Updated: December 14, 2023

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.