Recall Z-1053-2008
Draeger Medical, Inc. · initiated January 31, 2008
Product
Draeger Globe Trotter IC, Catalog Number: MU20509, Draeger Medical, Inc., Telford, PA 18969
Codes / lots: Serial Numbers: QT05675, QT05676, ST05708, and ST05704
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-1053-2008
- Initiated
- January 31, 2008
- Posted by FDA
- March 18, 2008
- Terminated
- May 8, 2008
- Product code
- FMZ – Incubator, Neonatal
- Quantity
- 4 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.
- Recalling firm
- Draeger Medical, Inc., Telford, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1051-2008 | Draeger TI500. Isolette Infant Incubator. Catalog Number: MU20505. Draeger Medical…Heating failure- The power board which controls the incubator heater may not regulate the temperature… | 01/31/2008Terminated |
| Z-1052-2008 | Draeger GT500. GlobeTrotter Transport System. Catalog Number: MU20508, Draeger Medical…Heating failure- The power board which controls the incubator heater may not regulate the temperature… | 01/31/2008Terminated |