Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:26739
Brand Name:Veradius/ Veradius Unity/ BV Systems/ Zenition
Model:Zenition 70 Systems - MODEL REF: 718133
Affected:
Software version:
Recalling Organisation:Philips New Zealand Commercial Limited
Level 3
123 Carlton Gore Road
Newmarket
AUCKLAND 1023
Contact Information:0800 251 400
Manufacturer:Philips Medical Systems Nederland BV
Issue:The manufacturer has found that the Instructions For Use provided with your system are missing information regarding the conditions of usage of the Flat Detector. Such information is required according to clause 11.1.2.2 of the IEC 60601-1, Edition 3.1, Medical electrical equipment-Part 1: General requirements for basic safety and essential performance.
Recall action type:Correction
Recall action:Instructions for use to be updated
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:21/10/2020
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