Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:22778
Brand Name:X-ray System
Model:C-Arm X-Ray System
Affected:
Software version:
Recalling Organisation:Ortho Medics Limited
586 Great South Road
Ellerslie
Auckland 1051
Contact Information:09 527 1203
Manufacturer:Ortho Scan Inc
Issue:The manufacturer has determined that there is a potential Hazard where the user should never select the Digital Zoom when Fluoroscopic X-ray beam is active. This allows the system to expose a larger x-ray field exposure than allowed beyond the image receptor field of view displayed on the monitor of the system by > 3% of SID.
Recall action type:Correction
Recall action:Software to be upgraded
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:6/4/2018
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