Osia Fitting Software 2
- Recalling firm
- Cochlear NZ Limited
- Product
- Osia Fitting Software 2. [Device]. Model: Cochlear Osia Fitting Software 2; Baha Fitting Software. Also covers: Baha fitting software
- Reason
- Following a change to a licence validation step by a third-party partner, since January 19, 2026, some clinicians have been prevented from opening the software and so were unable complete fitting or programming sessions., The specific versions impacted are:, · Osia Fitting Software version 2.1.6, 2.1.5 and 2.1.4, · Baha Fitting Software version 6.1.9 and 6.1.8, This issue does not impact the safety or clinical performance of the software; however, this can cause disruption to scheduled appointments and the programming of devices for patients.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-01-27
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/dcae13c9-b626-4f9a-a43f-2b6d5ff75df0