Recall Z-1480-2023— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1480-2023
Creator: U.S. Food and Drug Administration
Published: 2022-11-23

Class II · Ongoing

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2022-11-23. It names one FDA 510(k) clearance: K173639. Product: Luminos dRF Max (VE10, VF10, VF11). 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..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Ongoing
Initiated: 2022-11-23
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K173639 — Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom RaxSiemens Medi Cal Solutions, Inc.·cleared 2018-04-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Luminos dRF Max (VE10, VF10, VF11)

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.