| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00980-1 |
| Product Name/Description |
Zimmer A.T.S. 3000 Automatic Tourniquet System (used to temporarily occlude blood flow during surgery)
Product Code: 3011LACW
Serial Numbers: 3011LACS, 3011LACL, 3011LAED, 3012BAAB, 3012BAAF |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/09/2012 |
| Responsible Entity |
|
| Reason/Issue |
On some occasions during surgical procedures, the unit will fail, alarm, lock into a non-operational mode and the display screen will go blank. Based on Zimmer's investigations, this problem is due to a defective chip on the control board. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers are being asked to remove affected A.T.S 3000 tourniquet systems from use immediately & contact their sales representative who will return the unit to the company for repair and arrange a loan unit. |
| Contact Information |
02 9950 5400 - Zimmer Regulatory Affairs |