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Recall Observatory FDA recall evidence

Device product

LUMINOS Lotus Max (VF11)

Z-1481-2023

November 23, 2022

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 92229
Status
Ongoing
Classification
Class II
Quantity
704 units in the United States (1945 units worldwide)
Official record key
device-enforcement:Z-1481-2023

Official wording

Reason: 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.

Code information: Model: 11574100

Distribution pattern: US Nationwide - Worldwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.