Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:19019
Brand Name:Carestream DRX Evolution with DIRECTVIEW Software
Model:Carestream DRX Evolution with DIRECTVIEW Software
Affected:Versions 5.6 & greater, and V5.7 with DR LLI Auto Stitich
Software version:
Recalling Organisation:Carestream Health New Zealand Ltd
c/- Quigg Partners
Level 7, 28 Brandon St
Wellington
Contact Information:021 977 215
Manufacturer:Carestream Health Inc (HCIS)
Issue:Carestream Health has identified a software issue that impacts image alignment when using the automatic stitching option for long length images. If there is no use of external fiducial markers or measurement tools (eg. radio opaque ruler) when building a composite image and the technologist relies solely on the auto stitching software, there is a risk of undetected stitching errors.
Recall action type:Correction
Recall action:Software to be upgraded
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:26/8/2015
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