Recall Z-1051-2008 ยท FMZ Incubator, Neonatal
Draeger Medical, Inc.
Draeger TI500. Isolette Infant Incubator. Catalog Number: MU20505. Draeger Medical, Inc., Telford, PA 18969
| Date | Mar 18, 2008 (initiated Jan 31, 2008) |
| Status | Terminated |
| Reason | Heating failure- The power board which controls the incubator heater may not regulate the temperature properly resulting in a high temperature alarm and a loss of temperature control within the patient compartment. |
| Root cause | Nonconforming Material/Component |
| Action | The firm notified consignees on 2/1/08, by an Important Safety Notice. The letter instructed users to remove any units from use until a Draeger Service Representative can replace the power board. A Service Representative will be in contact to schedule a service visit. For questions concerning this recall please contact 215-660-2418 or Anbu.arasu@draeger.com. |
| Quantity | 18 units |
| Distribution | Worldwide Distribution-- USA including states MO, OH, and PR, and countries of Australia, Canada, Columbia, Israel, UAE, France, China, Italy, Denmark, Switzerland, and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K941106 | MODEL TI500 ISOLETTE INFANT INCUBATOR Air-Shields, Inc., Jun 10, 1994 |