Fisher and Paykel Healthcare — Class II medical device recall Z-0210-2015
Terminated recall by Fisher & Paykel Healthcare, Ltd., reported 2014-11-19, distributed nationwide. Breakage of the nut that secures the heater head in place, which can cause the heater head to become partially
| Recall number | Z-0210-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fisher & Paykel Healthcare, Ltd., Auckland, New Zealand |
| Recall initiated | 2014-11-06 |
| Classified | 2014-11-13 |
| Reported by FDA | 2014-11-19 |
| Terminated | 2015-04-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BH, BM, CL, CN, DE, DO, DZ, EE, ES, FI, FR, GB, GR, HK, HR, ID, IE, IL, IN, IR, IS, JO, KE, KW, LB, LK, LT, LV, MA, MX, MY, NG, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, QA, RO, RS, RU, SA, SG, SI, TH, TN, TR, TW, UY, VE, VN, ZA |
| Reason classes | device malfunction |
| Model numbers | 043041129, 043041130, 043041131, 043042359, 071116, 090810, 648040142, IW910XXX, IW920XXX, IW931XXX, IW932XXX, IW933XXX, IW934XXX, IW951XXX, IW952XXX, IW953XXX, IW954XXX, IW980XXX, IW990XXX |
Product
Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and Paykel; Healthcare CosyCot and Kit Replacement Head Case Assembly It is designed to assist with the thermoregulation of infants weighing up to 10kg and is used by labor and delivery rooms and pediatric intensive care units. Infant Warmers Model Number (REF) IW910XXX, IW920XXX, IW931XXX, IW932XXX, IW933XXX, IW934XXX, IW951XXX, IW952XXX, IW953XXX, IW954XXX, IW980XXX, IW990XXX Spare Parts Model Number (REF) 043041129, 043041130, 043041131, 043042359, 648040142
Reason for recall
Breakage of the nut that secures the heater head in place, which can cause the heater head to become partially detached and swing towards the bassinet. There is the potential that a heater head could contact a patient situated on the bassinet and cause a serious injury.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.