| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00969-1 |
| Product Name/Description |
ARTIS icono biplane, ARTIS icono floor and Artis pheno with Large Display
Product codes: 11327600, 11327700, 10849000
ARTG 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 |
9/11/2023 |
| Responsible Entity |
|
| Reason/Issue |
In Electrophysiology (EP) catheter laboratories there are many video sources to be displayed in one split screen layout on the Large Display. In case of shrinking the recording system video source, artefacts and/or loss of ECG/IECG details might occur.
The quality of displayed ECG/IECG waveforms might be reduced when displayed in a smaller segment on the Large Display compared to the native video output resolution of the recording system, and analysis of the waveforms might be challenging for the operator in the examination room. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
A dedicated scaling algorithm for ARTIS icono/pheno is in development which is meant to improve the ECG/IECG visualisation quality of recording systems video outputs displayed in shrink split screen window size on the Large Display.
Customers will be contacted when the correction is available.
Until the correction is available, customers should create at least one configuration to display a recording system segment in 1:1 video resolution as described in customer letter (supplied by the sponsor to affected customers). |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |