Draeger TI500. Isolette Infant Incubator. Catalog Number: MU20505. Draeger Medical, Inc., Telford, PA 18969
FDA Recall Z-1051-2008 · Posted 2008-03-18
Recalling FirmDraeger Medical, Inc.
Recall StatusTerminated
Product CodeFMZ
Date Initiated2008-01-31
Date Terminated2008-05-08
Product Quantity18 units
Reason for Recall
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.
Firm 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 [email protected].
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution-- USA including states MO, OH, and PR, and countries of Australia, Canada, Columbia, Israel, UAE, France, China, Italy, Denmark, Switzerland, and UK.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.