Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:28880
Brand Name:SyncVision
Model:SyncVision Systems (400-0100.10, 30000485688x) with software version 4.2.x are affected
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:Volcano Corporation
Issue:The manufacturer has become aware of an anomaly with the Philips Volcano (SyncVision Systems (400-0100.10, 30000485688x).
The issue is limited to cases when:
The SyncVision runs the current supported software version 4.2.x AND
The secondary modality (IntraSight Integrated IVUS) runs software version 5.x.
Recall action type:Correction
Recall action:Instructions for use to be updated
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:25/1/2022
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