Recall Z-1955-2009 ยท FMT Warmer, Infant Radiant
Draeger Medical Systems, Inc.
Stabilet Infant Warming System, model numbers 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200.
| Date | Aug 25, 2009 (initiated Jul 17, 2009) |
| Status | Terminated |
| Reason | Hot particles fell into the infant bassinet beneath a Radiant Infant Warmer. The resulting fire injured an infant. These devices are obsolete. |
| Root cause | Equipment maintenance |
| Action | On 7/20/09, Draeger Medical, the recalling firm, issued a press release to medical media outreach organizations and an Urgent Medical Device letter to all known customers. This information explained the incident and the need to remove and replace the units in question as soon as feasibly possible. |
| Quantity | 6489 units |
| Distribution | Worldwide distribution: USA, Brazil, Canada, China, Dominican Republic, France, Korea, Lebanon, Mexico, Nigeria, Panama, Poland, Saudi Arabia, Taiwan, Turkey, United Kingdom, Uruguay, and Venezuela. |
| FDA record | Open on fda.gov |