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Manufacturers
Fisher & Paykel Healthcare Pty Ltd
Manufacturer Parent Company (2017)
Fisher & Paykel Healthcare Corporation Limited
Source
DHTGA
6 Events
Recall of F & P SleepStyle CPAP Device Devices using V1.1.0 firmware
Recall of Catheter Mount
Recall of AIRVO 2 / myAIRVO 2 HumidifierAIRVO 2 Humidifier
Recall of Fisher & Paykel Healthcare Infant Warmer Pivot Securing Nut Infant Warmers
Recall of Infant Nasal CPAP Prongs and Bubble CPAP Starter Kits
Recall of Adult Circuit Tubing (Oxygen therapy delivery system)
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6 devices in the database
F & P SleepStyle CPAP Device Devices using V1.1.0 firmware
Model / Serial
F & P SleepStyle CPAP Device Devices using V1.1.0 firmwareModel Number; SPSAAA, SPSCAABatch Numbers: SPSAAA: 2100199626 - 2100401417SPSCAA: 2100194431 - 2100302650ARGT Number: 227979 (Fisher & Paykel Healthcare - OSA CPAP Therapy devices - Home CPAP unit)
Catheter Mount
Model / Serial
Catheter MountModel Number: RT021 Lot Numbers: From 2100089358 to 2100098462; and From 2100190360 to 2100241254ARTG Number: 273356
AIRVO 2 / myAIRVO 2 HumidifierAIRVO 2 Humidifier
Model / Serial
AIRVO 2 / myAIRVO 2 HumidifierAIRVO 2 HumidifierModel Number: PT101XXmyAIRVO 2 HumidifierModel Number: PT100XXAffected Serial Numbers: 120521YYYYYY – 160605YYYYYYARTG Number: 177298
Fisher & Paykel Healthcare Infant Warmer Pivot Securing Nut Infant Warmers
Model / Serial
Fisher & Paykel Healthcare Infant Warmer Pivot Securing Nut Infant WarmersModel Numbers: IW910XXX, IW920XXX, IW931XXX, IW932XXX, IW933XXX, IW934XXX, IW951XXX, IW952XXX, IW953XXX, IW954XXX, IW980XXX & IW980XXXSerial Numbers: 071116ZZZZZZ to 090810ZZZZZZSpare Parts:Model Numbers: 043041129, 043041130, 043041131, 043042359, 648040142Lot Numbers: 071116 - 090810 (all spare parts) ARTG number: 100660
Infant Nasal CPAP Prongs and Bubble CPAP Starter Kits
Model / Serial
Infant Nasal CPAP Prongs and Bubble CPAP Starter KitsAffected model numbers / lots numbersARTG Numbers: 129354 & 141298
Product Classification
Anesthesiology Devices
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