Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:15928
Brand Name:APS EVOTECH Integrated Endoscope Disinfection System
Model:Model: 50004
Affected:
Software version:
Recalling Organisation:Johnson & Johnson (New Zealand) Limited
507 Mt Wellington Highway
Mt Wellington
AUCKLAND 1060
Contact Information:0800 922 638
Manufacturer:Advanced Sterilization Products Inc
Issue:The manufacturer of EVOTECH® Endoscope Cleaner and Reprocessors (ECR) has discovered that the EVOTECH® ECR may cancel cycles when reprocessing the Pentax EG-3670URK flexible endoscope. The Pentax EG-3670URK flexible endoscope has been qualified for use with the EVOTECH® ECR, however it cannot currently be processed in the EVOTECH® ECR due to incorrect flow rate parameter programming in the system that is specific to this endoscope. The minimum flow rate has been programmed at levels higher than those required for effective cleaning of this scope which leads to cycle cancellation for error of Low Flow.
Recall action type:Correction
Recall action:Software to be upgraded
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:20/12/2013
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