| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01068-1 |
| Product Name/Description |
A.T.S. 2200 and A.T.S. 4000 Tourniquet Systems
ATS2200TS with hoses
Item Number: 60-2200-101-00
Serial Number (prefix only): 2214-2216
ATS4000TS with hoses
Item Number: 60-4000-101-00
Serial Number (prefix only): 4014-4016
ARTG Number: 95696 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
16/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
Zimmer Biomet has received a total of 14 complaints that the ATS 2200 spontaneously inflates the secondary cuff without any user input. Zimmer Biomet is providing an on-device label and an updated Operator/Service Manual. A Medical Device Corrective action for the ATS 2200 and ATS 4000 Tourniquet Systems is being implemented utilising a shortened separation distance of 1.0 metre between RF communication equipment, in order to mitigate the potential for electromagnetic interference and achieve optimal performance of the tourniquet machines.
There have been no injuries or deaths reported to date as a result of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Zimmer is requesting that customers:
1.Review the notification and ensure affected personnel are aware of the contents;
2.Confirm the receipt of the on-device label and 3 pages of the updated Operator/Service Manual provided with the customer letter;
3.Place the label on the device in the specified location;
4.Replace the 3 pages of the Operator/Service Manual with the updated pages; and
5.Email a completed copy of the supplied Attachment 1 form to RAQA.ANZ@Zimmerbiomet.com to confirm that they have placed the label in the specified location on the device and replaced the 3 pages of the Operator/Service Manual with the updated pages.
This action has been closed out on 15/10/2018 |
| Contact Information |
02 9483 5426 - Zimmer Biomet |