Intelerad Medical Systems - Inteleshare

Recalling firm
Clinical & Regulatory Services Limited
Product
Intelerad Medical Systems - InteleShare. [Device]. Model: InteleShare (cloud-hosted; no client-installed component). All releases from 3.25.2.0 onward – 3.25.2, 3.26.1, 3.26.2, and 3.26.3 lines.
Reason
The manufacturer has become aware of two problems affecting certain versions of InteleShare., Problem 1 – Incomplete Study Duplication in InteleShare, When a study is duplicated from one account/namespace to another while images are still arriving, only the images present at the time of the first copy are transferred. Follow-up copy requests occasionally fail and the destination study remains incomplete., Problem 2 – Incomplete Image Archival in InteleShare, Under certain conditions during study archiving or deletion, DICOM images may be removed from primary storage without being preserved...
Classification
Class I
Category
medical device recall
Country
New Zealand
Agency
MEDSAFE
Recall date
2026-11-04
Status
Ongoing
Distribution
New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/bce38a06-607c-4a3a-b746-45bf6117c1cc