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Sign in to claim this brandFISHER & PAYKEL HEALTHCARE, LTD.
NZ
Last updated September 17, 2026
Information
- Country
- NZ
- Address
- 15 MAURICE PAYKEL PLACE, EAST TAMAKI Auckland
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3002806988
- DUNS Number
- —
Catalogue (0)
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FDA Recalls (15)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 22, 2013 | Z-1437-2013 | — | terminated | Fisher and Paykel Healthcare is recalling the ICON CPAP units because there is a potential power issue on certain ICON CPAP. These ICON CPAP units could potentially become inoperable, which would result in a lack of treatment to the patient's obstructive sleep apnea symptoms until a replacement unit is obtained. |
| Nov 19, 2012 | Z-0621-2013 | — | terminated | FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes were incorporated by FPH into certain 900MR068 reusable circuits with lot numbers 110810 and 111020. If this hole damage is not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the int |
| Oct 22, 2008 | Z-0414-2009 | — | terminated | The recall was initiated because certain lot dates of the RT240 Adult Breathing Circuit Kits manufactured on or before June 27, 2008 include a heated breathing circuit that may be more susceptible to damage when used in excess of the specified seven-day maximum duration of use, which may increase the risk of malfunction or fire. |
| Nov 24, 2006 | Z-0969-2007 | — | terminated | Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it may enter the CPAP system air path and there is an extremely remote possibility that the broken tab may then enter the patient's nasal cavity or mouth. Masks manufactured since April 2006 do not featu |
| Nov 24, 2006 | Z-0971-2007 | — | terminated | Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it may enter the CPAP system air path and there is an extremely remote possibility that the broken tab may then enter the patient's nasal cavity or mouth. Masks manufactured since April 2006 do not feat |
| Nov 24, 2006 | Z-0970-2007 | — | terminated | Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it may enter the CPAP system air path and there is an extremely remote possibility that the broken tab may then enter the patient's nasal cavity or mouth. Masks manufactured since April 2006 do not feat |
| Nov 24, 2006 | Z-0972-2007 | — | terminated | Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it may enter the CPAP system air path and there is an extremely remote possibility that the broken tab may then enter the patient's nasal cavity or mouth. Masks manufactured since April 2006 do not feat |
| Nov 24, 2006 | Z-0974-2007 | — | terminated | Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it may enter the CPAP system air path and there is an extremely remote possibility that the broken tab may then enter the patient's nasal cavity or mouth. Masks manufactured since April 2006 do not feat |
| Nov 24, 2006 | Z-0973-2007 | — | terminated | Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it may enter the CPAP system air path and there is an extremely remote possibility that the broken tab may then enter the patient's nasal cavity or mouth. Masks manufactured since April 2006 do not feat |
| Dec 20, 2005 | Z-0697-06 | — | terminated | Risk of fire. The manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. This may lead to a potential risk of fire. |
| Dec 20, 2005 | Z-0696-06 | — | terminated | Risk of fire. The manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. This may lead to a potential risk of fire. |
| Dec 20, 2005 | Z-0695-06 | — | terminated | Risk of fire. The manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. This may lead to a potential risk of fire. |
| Dec 20, 2005 | Z-0694-06 | — | terminated | Risk of fire. The manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. This may lead to a potential risk of fire. |
| Dec 21, 2004 | Z-0553-05 | — | terminated | Pressure elbow may be partly occluded. |
| Dec 5, 2003 | Z-0241-04 | — | terminated | Component placement presents risk of electrocution to patients. |
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Fisher & Paykel Healthcare, Inc. IRVINE, CA · US FEI 3000210616