Hexavue Focus Integration System

Recalling firm
Steris New Zealand Limited
Product
HexaVue Focus Integration System. [Device]. Model: HexaVue Focus system that is running software version 2.0.18.
Reason
The manufacturer identified through customer complaints that a software issue may result in unintended mismatch of patient information on manually printed images. Specifically, during an active procedure for Patient A, a user may manually select a different patient record (Patient B) from the �Patient Cases� menu and subsequently manually print images. In this specific manual print workflow, the printed output may display patient identifying information from the selected patient record (Patient B) rather than the active procedure (Patient A), including patient name, date of birth, and...
Classification
Class I
Category
medical device recall
Country
New Zealand
Agency
MEDSAFE
Recall date
2026-09-15
Status
Ongoing
Distribution
New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/7da2d879-2cfc-4fc6-abf7-1864f8f26411