| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00836-1 |
| Product Name/Description |
ARTIS Q, ARTIS pheno systems and X-ray generator
Catalogue Numbers: 10848282, 10848281, 10848280, 10848283, 10848355, 10849000
ARTG Number: 273952
(Siemens Healthcare Pty Ltd - X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/06/2018 |
| Responsible Entity |
|
| Reason/Issue |
Siemens have identified that in the event of a short-circuit within the X-ray tube, a current leakage may cause an overload of the X-ray generator. If this current leak remains undetected it may cause damage to the generator by overheating after-which, taking an X-ray will not be possible. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Siemens are advising they will contact customers to schedule the installation of a Residual Current Device (RCD) on affected generators in order to detect current leakages.
This action has been closed out on 31/05/2019 |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |