Gn Hearing Mdr Ite
- Recalling firm
- GN Hearing New Zealand Limited
- Product
- GN Hearing MDR ITE. [Device]. Model: Part number/Model - NX7ITE-DWC-UP, 5NXWLDEHPAG. Affected: Serial number - 2616000084, 2616000085, 2652010764, 2652010765
- Reason
- The manufacturer has identified that some devices manufactured between 6 and 13 February 2026 cannot be programmed because they are unable to connect to the fitting software. The affected devices cannot be programmed and therefore do not perform their intended function. As the devices cannot be programmed, they cannot be fitted or used on patients. There is no risk to patient safety associated with this issue.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-03-05
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/b3f4e4f0-59d2-49d1-8984-e9a0c6e4f49c