| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01177-1 |
| Product Name/Description |
Welch Allyn Schiller AG 1500 Monitor (multi parameter patient monitor)
ARTG Number: 181948 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
29/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
Welch Allyn has advised that they inadvertently shipped the incorrect User Manual and Quick Reference guide for the Welch Allyn 1500 Monitor, which did not include some additional functions available in the device, which include Cardiac Output, hemodynamin and Integrated Pulmonary Index (IPI). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Updated Instructions for Use (IFU) will be issued. |
| Contact Information |
02 9638 3000 - Welch Allyn Technical Support |