—#208916

Product

LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 11574100

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K173639
Affected lot / code info: UDI: (01)04056869269931(21) Serial Numbers: Serial Number 10251 10181 10278 10274 10115 10309 10024 10140 10073 10327 10091 10307 10253 10117 10311 10030 10194 10029 10063 10076 10173 10172 10170 10079 10234 10330

Why it was recalled

The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Siemens issued Customer Safety Advisory Notice (CSAN) XP017/24/S to Director of Diagnostic Imaging and/ or Radiology Laboratory on 7/2/24. Letter states reason for recall, health risk and action to take: Please visually inspect the mounting screw on the ceiling tube (Figure 1) or wall tube (Figure 2) of the display suspension as far as this is possible from the floor. In case the visual inspection of the mounting screw does not show any abnormalities, you can continue to use the system. Nevertheless, until the system has been checked by Siemens Healthineers customer service with the planned field action, we recommend: - not to swivel the support arm of the display ceiling/wall suspension to the mechanical limit with great force and - to ensure that there is no one under the display ceiling/wall suspension when positioning the displays. This Customer Safety Advisory Notice (XP017/24/S) is being distributed to all potentially affected customers. Siemens Healthineers is preparing a field safety corrective action that will be provided with Update XP018/24/S starting in the third quarter of 2024. The corrective action will involve check and replacement of the attachment of the support arm for the display ceiling/wall suspension by a service technician in an onsite visit. In instances where the mounting screw is broken, the support arm will also be replaced with update XP019/24/S. These field actions will be provided to you free of charge. Once the corrective actions are available, our customer service team will contact you to schedule an appointment to perform the above safety corrective action(s). Once the updates are available and if you would like to make an earlier appointment, please feel free to contact customer service at 1-800-888-7436. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Customer Safety Advisory Notice. Please respond within 14 days of receiving this notification

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2024-07-02
Posted by FDA: 2024-08-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208916. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.