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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 Siemens Healthcare Pty Ltd
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