Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:27896
Brand Name:CPAP Systems
Model:
Affected:All serial numbers
Software version:
Recalling Organisation:Philips New Zealand Commercial Limited
Level 3
123 Carlton Gore Road
Newmarket
AUCKLAND 1023
Contact Information:0800 251 400
Manufacturer:Respironics Inc
Brand Name:BiPAP C-Series Ventilatory Support System
Model:
Affected:All serial numbers
Software version:
Recalling Organisation:Philips New Zealand Commercial Limited
Level 3
123 Carlton Gore Road
Newmarket
AUCKLAND 1023
Contact Information:0800 251 400
Manufacturer:Respironics Inc
Brand Name:System One Pro/Auto, DreamStation
Model:
Affected:All serial numbers
Software version:
Recalling Organisation:Philips New Zealand Commercial Limited
Level 3
123 Carlton Gore Road
Newmarket
AUCKLAND 1023
Contact Information:0800 251 400
Manufacturer:Respironics Inc
Brand Name:DreamStation BiPAP
Model:
Affected:All serial numbers
Software version:
Recalling Organisation:Philips New Zealand Commercial Limited
Level 3
123 Carlton Gore Road
Newmarket
AUCKLAND 1023
Contact Information:0800 251 400
Manufacturer:Respironics Inc
Brand Name:BiPAP autoSV, DreamStation BiPAP autoSV
Model:
Affected:All serial numbers
Software version:
Recalling Organisation:Philips New Zealand Commercial Limited
Level 3
123 Carlton Gore Road
Newmarket
AUCKLAND 1023
Contact Information:0800 251 400
Manufacturer:Respironics Inc
Brand Name:DreamStation AVAPS
Model:
Affected:All serial numbers
Software version:
Recalling Organisation:Philips New Zealand Commercial Limited
Level 3
123 Carlton Gore Road
Newmarket
AUCKLAND 1023
Contact Information:0800 251 400
Manufacturer:Respironics Inc
Brand Name:Dorma 500
Model:
Affected:All serial numbers
Software version:
Recalling Organisation:Philips New Zealand Commercial Limited
Level 3
123 Carlton Gore Road
Newmarket
AUCKLAND 1023
Contact Information:0800 251 400
Manufacturer:Respironics Inc
Brand Name:OmniLab Advanced +
Model:
Affected:All serial numbers
Software version:
Recalling Organisation:Philips New Zealand Commercial Limited
Level 3
123 Carlton Gore Road
Newmarket
AUCKLAND 1023
Contact Information:0800 251 400
Manufacturer:Respironics Inc
Brand Name:Philips Respironics E30 Ventilator
Model:
Affected:All serial numbers
Software version:
Recalling Organisation:Philips New Zealand Commercial Limited
Level 3
123 Carlton Gore Road
Newmarket
AUCKLAND 1023
Contact Information:0800 251 400
Manufacturer:Respironics Inc
Issue:The manufacturer has identified two (2) issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips Continuous and Non-Continuous Ventilators: 1) PE-PUR foam may degrade into particles which may enter the device's air pathway and be ingested or inhaled by the user, and; 2) the PE-PUR foam may off-gas certain chemicals. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone, and off-gassing may occur during operation.
Recall action type:Recall
Recall action:Product to be modified
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:2/7/2021
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