Draeger Medical and FDA notified healthcare professionals that it recommends the removal of Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 from service as soon as possible due to concern that continued use of these devices may result in serious injury to the patient and/or caregiver. A January 2008 fire in a Minnesota neonatal unit injured an infant and an independent investigation concluded that the Hill-Rom Stabilet 1250 was likely the ignition source of the fire. Draeger agrees with the recommendation to remove the referenced Stabilet models from service immediately. Immediate actions required include:

Locate and identify the devices listed in this notice.

Remove the referenced devices from service as soon as possible.

Once removed from service, the warmers should be rendered unusable by removing the heating element and the power cord. These warmers should not be used or sold for any other purpose.

If an infant is currently receiving therapy from one of the referenced devices, consider the risk of moving the patient before changing to an alternative mode of therapy

Source
FDA