Recall Z-0223-2024— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0223-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-05

Class II · Ongoing

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2023-10-05. It names one FDA 510(k) clearance: K111912. Product: Mobilett Mira wireless (VA20) mobile x-ray system(s). Reason: Due to the incorrect mounting of the buzzer component, there is no acoustic signal during x ray activation. Otherwise, the system is fully functional, and x ray is applied correctly. By means of the additional visual indicator (exposure LED light) the operator can monitor the x ray release. Also, after a successful x ray exposure, the clinical image is displayed on the monitor..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-10-05
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K111912 — MOBILETT MIRASiemens Medical Solutions USA, Inc.·cleared 2011-09-19

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

Mobilett Mira wireless (VA20) mobile x-ray system(s)

Reason for recall

Due to the incorrect mounting of the buzzer component, there is no acoustic signal during x ray activation. Otherwise, the system is fully functional, and x ray is applied correctly. By means of the additional visual indicator (exposure LED light) the operator can monitor the x ray release. Also, after a successful x ray exposure, the clinical image is displayed on the monitor.

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