Draeger TI500. Isolette Infant Incubator. Catalog Number: MU20505. Draeger Medical, Inc., Telford, PA 18969
This recall has been terminated (originally issued March 18, 2008).
- Company
- Draeger Medical, Inc.
- Recall Initiated
- January 31, 2008
- Posted
- March 18, 2008
- Terminated
- May 8, 2008
- Recall Number
- Z-1051-2008
- Quantity
- 18 units
- Firm Location
- Telford, PA
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Serial Numbers: PK05967, PK05990, PK05973, PK05986, PK05987, PK05988, PK05962, PK05963, PK05964, PK05965, PK05989, PK05976, PK05972, LT05951, PK05968, LT05952, PK05969, and PK05974.
Root 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.