Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:28826
Brand Name:Fetal Spiral Electrode
Model:
Affected:Instructions IFU
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
Issue:Between September 2012 and September 2021, the manufacturer continued to include a 2007 edition of the IFU with the Fetal Spiral Electrode product. This previous edition did not include the following warning messages in the Warnings section of the IFU:
Reuse may cause degradation of physical or electrical properties
" Do not reuse on another patient due to risk of cross-infection
Recall action type:Correction
Recall action:Instructions for use to be updated
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:13/1/2022
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