ANZCDACC Product Defect Correction Notification
Merlin™ Patient Care System (PCS) Software Model 3330 v25.0.X–v25.3.X
When used with
Abbott Gallant™, Neutrino™ NxT, Entrant™ devices
- In Australia; Neutrino™ NxT and Entrant ™ are currently approved but not commercially launched (Only Gallant is commercially available).
- In New Zealand; Only Gallant and Entrant are Medsafe WAND notified however only Entrant has been commercially launched at limited accounts.
Australian Register of Therapeutic Goods (ARTG):
Advisory grade TGA:
Class II- A situation in which use of, or exposure to, the deficient therapeutic good(s) may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.