Recall Z-1479-2023— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1479-2023
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 Agile 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. Siemens Healthineers became aware of one customer site where this issue was identified during clinical operation..

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 Agile 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. Siemens Healthineers became aware of one customer site where this issue was identified during clinical operation.

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