Multitom Rax -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 10860700
FDA Recall Z-2528-2024 · Posted 2024-08-07
Advertisement
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2024-07-02
Product Quantity0
Reason for Recall
The support arm may unintentionally lower resulting in injury to persons when they are under the
display ceiling/wall suspension when positioning the displays
Firm Action
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
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement