| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00445-1 |
| Product Name/Description |
Ultraview SL Command Module
(Patient monitoring system)
Modules shipped or repaired after 8 March 2015
Catalogue number: 91496
ARTG number: 109585 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
Due to a software defect the Ultraview SL Command Module can in advertently reset. The reset sequence takes approximately 10 seconds and during this period monitoring of all parameters will be suspended. Upon completion of the reset sequence, all alarm limits will be reset to their site-defined default values. Critical alarms for ventricular fibrillation and asystole are always enabled after the reset. If invasive pressure is being monitored, labels will be reset to default values and the zero calibration will be lost. If non-invasive pressure is being monitored, the automatic measurement mode will be disabled.
A separate failure mode can also occur where the SpO2 menu keys become unresponsive and prevent user changes to SpO2 operation and alarm settings. In this state, all alarm limits, alarm functions and parameter monitoring continue unaffected and all alarm limits other than SpO2 can still be adjusted. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Medtel Pty Ltd will contact users to schedule a convenient time to correct all of the affected Ultraview SL Command Modules at no cost. This action has been closed-out on 11/08/2016. |
| Contact Information |
1300 886 385 - Medtel Pty Limited |