| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00667-1 |
| Product Name/Description |
ARTIS pheno systems
Catalogue Number: 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 |
31/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
Siemens is advising of a potential issue with ARTIS pheno systems. During manual rotation of the C-arm at maximum speed, the system's safety stop mechanism may be activated. As a result, the C-arm of ARTIS pheno stops the rotation and can drop up to 40 mm {1.6 "). This can happen during an ongoing procedure. If this problem occurs, the system performs a safety stop. The system can then be operated normally again.
Under certain circumstances, the cover of the detector or collimator can touch and possibly injure the patient due to the drop caused by this safety stop. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
As an immediate measure, Siemens' service organisation limits the maximum manual LAO/ RAO rotation from 25°/sec to 20°/sec and Cran/Caud rotation from 20°/sec to 10°/sec. All other system parameters as well as 3D acquisition and Perivis ion/Peristepping remain unaffected.
Siemens are working on a solution to restore the system back to the original settings, and their service organisation will contact affected users to arrange an appointment to carry out the corrective action.
This action has been closed out on 27/02/2019 |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |