FDA Device

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 u

Hazard

Risk associated with operating the device in skin temperature mode with temperature sensors attached but no patient connected.

What You Should Do

Remedy

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).

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Products

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
Brand
Draeger Medical, Inc.
UPC
Serial Numbers: ARLN-xxxx to ASFE-xxxx Catalog Numbers: FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004)

Units Affected

1,599 units

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