Recall Z-2295-2016 ยท FMT Warmer, Infant Radiant
Draeger Medical, Inc.
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,
| Date | Jun 22, 2016 |
| Status | Terminated |
| Reason | Risk associated with operating the device in skin temperature mode with temperature sensors attached but no patient connected. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971198 | BABYTHERM 8004 BABYTHERM 8010 Drager, Inc., Oct 3, 1997 |