Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:21944
Brand Name:Measurement Modules
Model:
Affected:The ECG 12-lead option #C12
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 Medizin Systeme Boblingen GmbH
Brand Name:Patient Monitors
Model:
Affected:The ECG 12-lead option #C12
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 Medizin Systeme Boblingen GmbH
Issue:The manufacturer has recently discovered that when performing 12-lead ECG monitoring, if an affected monitor detects and alerts the user that the ECG lead set is damaged or otherwise not performing appropriately, it will apply corrective filtering that can distort the ST-segment, which could contribute to a misdiagnosis or a misinterpretation causing a delayed or even an incorrect treatment if relied on by the user.
Recall action type:Correction
Recall action:Software to be upgraded
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:7/9/2017
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