Babytherm 8004/8010 — Class II medical device recall Z-2295-2016
Terminated recall by Draeger Medical, Inc., reported 2016-08-03, distributed nationwide. Risk associated with operating the device in skin temperature mode with temperature sensors attached but no pa
| Recall number | Z-2295-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Draeger Medical, Inc., Telford, PA, United States |
| Recall initiated | 2016-06-22 |
| Classified | 2016-07-28 |
| Reported by FDA | 2016-08-03 |
| Terminated | 2016-12-07 |
| Distributed | Nationwide (US) |
| Quantity | 1,599 units |
| Model numbers | FR00105 |
Product
Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004), non sterile, software controlled. Product Usage: Babytherm 8004/8010 is an open care infant warmer system for warming premature babies, neonates and infants with a body weight of up to 8 kg (17.6 lbs). The device is intended for use in delivery rooms, operating rooms, maternity and obstetric units, neonatal and pediatric wards, neonatal and pediatric intensive care units. Therapy and nursing uses: - As a resuscitation table and in birthing rooms, obstetric units, and NICUs - As infant warmer bassinet during normal and intensive care - For infant re-warming and compensation of heat loss - For thermal stabilizing of infants with mattress heater (Babytherm 8010 only) - For gentle warming therapy using the combination of radiant and mattress heater - Cooling infants with fever (temperature of mattress below infant body temperature, Babytherm 8010 only) - With adjustable bed tilt for treatment of infants in Trendelenburg and reverse Trendelenburg position - For weaning infants from incubators - For O2 and nebulizer therapy (with appropriate accessories) - For lowering an infant s bilirubin levels when using the phototherapy option
Reason for recall
Risk associated with operating the device in skin temperature mode with temperature sensors attached but no patient connected.
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.