Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21721 |
| Brand Name: | HF-buttons, needles (Germany) |
| Model: | |
| Affected: | HF Resection Electrode |
| Software version: | |
| Recalling Organisation: | Olympus (NZ) Ltd 15D Paul Matthews Road Albany Auckland |
| Contact Information: | 0508 659 6787 |
| Manufacturer: | Olympus Winter & Ibe GmbH |
| Brand Name: | HF Resection Electrode_TURis |
| Model: | |
| Affected: | IEC 60601-1 3rd edition |
| Software version: | |
| Recalling Organisation: | Olympus (NZ) Ltd 15D Paul Matthews Road Albany Auckland |
| Contact Information: | 0508 659 6787 |
| Manufacturer: | Olympus Winter & Ibe GmbH |
| Issue: | The IFU has been updated to include new contraindications, warnings and safety information. The contraindications information have been added as a part of the FDA guidance for "Hysteroscopes and Gynaecologic Laparoscopes Submission Guidance for 510k". The warnings and safety information have been added as a result of an update to the IEC 60601-1 3rd edition, standard requirements. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 25/7/2017 |
