Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:25896
Brand Name:ICS Impulse
Model:
Affected:Multiple Serial number
Software version:
Recalling Organisation:Natus Medical New Zealand Limited
Alliott NZ Ltd
Level 2, 142 Broadway
Newmarket
Auckland 1149
Contact Information:0800 900 126
Manufacturer:Natus Medical Denmark ApS
Issue:The affected devices were incorrectly shipped to European countries without fulfilling the requirements of EN 60601-1-2:2015 (IEC 60601-1- 2:2014 4th Edition) - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests. Compliance to the standard is a requirement of CE marking as of 31st Dec 2018.
Recall action type:Recall
Recall action:Product to be returned to supplier
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:3/4/2020
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