| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01109-1 |
| Product Name/Description |
Artis systems with large display module
Siemens Material Numbers: 10094135, 10094137, 10094141, 10094142, 10280959, 10848280, 10848281, 10848282, 10848283, 10848354 and 10848355
ARTG Number: 102177 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/11/2015 |
| Responsible Entity |
|
| Reason/Issue |
Due to improper soldering in limited components of a specific production lot of large display bypass module, a loss of video signal could potentially occur (will not show any image). Radiation can still be applied without image, which could result in dose to the patient without clinical benefit. The error has not been observed in the field. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens will be replacing any potentially affected units with unaffected stock. This action has been closed-out on 24/08/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |