| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00923-1 |
| Product Name/Description |
Luminos dRF and Luminos dRF Max systems
(Fluoroscopic diagnostic x-ray systems)
Luminos dRF systems with software version VD10
Catalogue Number: 10094200
Luminos dRF Max systems with software version VE10
Catalogue Number: 10762471
ARTG Number: 102182 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/08/2014 |
| Responsible Entity |
|
| Reason/Issue |
There is the potential for malfunction when exposing the table side control panel of the Luminos dRF / Luminos dRF Max system to fluids. If the panel is infiltrated by fluids, malfunctions may occur when buttons on the control panel are pressed, in the worst case the patient may slip off the table if the table is activated erroneously. In a very unlikely scenario, fluid may cause a permanent short circuit within the control panel and automatically disable the affected button(s) with the start-up of the system. In this case the system remains functional as it can be operated via the remote control panel. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising end users to avoid extensive exposure of fluids to the table side control panel when using the system. When cleaning the system, please make sure that you do not apply excessive fluids: i.e., only use damp towels, in accordance with the product manual. The remote control panel is not affected by any malfunction of the table side control panel and can reliably be used at any time.
Siemens is currently working on a permanent solution to eliminate the risk of fluid infiltration. This action has been closed-out on 24/05/206. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |