Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21816 |
| Brand Name: | Tourniquet Systems |
| Model: | |
| Affected: | updating an on-device label on ATS2200 and ATS4000 units |
| Software version: | |
| Recalling Organisation: | Zimmer Biomet New Zealand Company 210 Khyber Pass Road Grafton Auckland |
| Contact Information: | 09 925 5200 |
| Manufacturer: | Zimmer Surgical, Inc. |
| Issue: | In a typical OR setting, the manufacturer originally recommended a minimum separation distance of 3.8 meters (m) between RF communication equipment to mitigate the potential for electromagnetic interference and to achieve optimal performance of the tourniquet machines. RF equipment consists of, but is not limited to, electrosurgical equipment, including any consoles, wiring, and pencil units. This distance recommendation originates from IEC 60601-1-2. As a result of customer feedback, additional internal testing was performed to see if this distance could be shortened, and it was determined that 1.0 meter provided adequate distance to avoid interference. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 14/8/2017 |
