| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00040-2 |
| Product Name/Description |
PS900 Power Module supplied with 12 Lead ECG Interp. 210mm Basic Monitors
Product code: ED-SE-1200E-B
Serial numbers of the monitors affected:
60531-M15901020001
60531-M15901020002
60531-M15901020003
60531-M15901020005
60531-M15901020009
60531-M15904540002
60531-M15904540003
11076-M15904530001
11076-M15904530002
11076-M15904530003
11076-M15904530004
11076-M15904530005
ARTG Numbers: 178086 and 236697 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
18/01/2016 |
| Responsible Entity |
|
| Reason/Issue |
A quality issue has been identified, relating to an incorrect power status indication with the PS900 power module supplied with the affected patient monitoring products. The products with the defective power module installed can generate false "Battery Low" alarms, and may have an incorrect power status shown on the screen.
The battery cannot be used in its current state as it cannot be recharged. However, the products can continue to be used the by plugging them into main power. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The sponsor is advising users that the affected devices can continue to be used provided that they are connected to a main power. The sponsor will contact the affected users to arrange for a firmware upgrade and/or the replacement of the power module. This action has been closed-out on 16/05/2017. |
| Contact Information |
02 8244 3744 - Device Technologies |