Z-2295-2016Class II

Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010)...

Name: Z-2295-2016 Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010)...
Creator: Draeger Medical, Inc.
Published: 2016-06-22
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2016-06-22 / Terminated / root cause: manufacturing process

FDA source

Draeger Medical, Inc. began a recall of Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004), non sterile, software... on 2016-06-22. FDA classified it as Class II and gives the reason as "Risk associated with operating the device in skin temperature mode with temperature sensors attached but no patient connected". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2295-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-22
Posted: 2016-07-28
Terminated: 2016-12-07
Recalling firm: Draeger, Inc.
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
Product code: FMT Warmer, Infant Radiant
Reason for recall: Risk associated with operating the device in skin temperature mode with temperature sensors attached but no patient connected.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Drager mailed to customers an Urgent Medical Device Recall Notification Letter dated June 22, 2016 to affected customers. The letter identified the affected product, problem information on how to operate the device and replacement of parts information. For questions regarding this letter please call 1-800-543-5047 (press 1 at the prompt, then 2, then 32349). For questions regarding the operation and/or servicing of your Drger Babytherm 8004/8010 please contact DrgerService Technical Support at 1-800-543-5047 (press 4 at the prompt).
Quantity in commerce: 1,599 units
Distribution: US Nationwide Distribution including Puerto Rico and the states of AK,AL,AR,CA,CO,CT,DE,FL,GA,HI,IA,IL,IN,KS,KY,LA,MA,MD,MI,MN,MO,MS,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,RI,SC,TN,TS,TX,UT,VA,WA,WI,WV, and WY.
Product codes and lots: Serial Numbers: ARLN-xxxx to ASFE-xxxx Catalog Numbers: FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2295-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2295-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-28

Product code FMT

K971198Class IIBabytherm 8004 Babytherm 8010Drager, Inc. / cleared 1997-10-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)