Draeger Medical, Inc. Draeger TI500. Isolette Infant Incubator. Catalog Number: MU20505. Draeger Medical, Inc., Telford, PA 18969 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Draeger TI500. Isolette Infant Incubator. Catalog Number: MU20505. Draeger Medical, Inc., Telford, PA 18969
Brand
Draeger Medical, Inc.
Lot Codes / Batch Numbers
Serial Numbers: PK05967, PK05990, PK05973, PK05986, PK05987, PK05988, PK05962, PK05963, PK05964, PK05965, PK05989, PK05976, PK05972, LT05951, PK05968, LT05952, PK05969, and PK05974.
Products Sold
Serial Numbers: PK05967, PK05990, PK05973, PK05986, PK05987, PK05988, PK05962, PK05963, PK05964, PK05965, PK05989, PK05976, PK05972, LT05951, PK05968, LT05952, PK05969, and PK05974.
Draeger Medical, Inc. is recalling Draeger TI500. Isolette Infant Incubator. Catalog Number: MU20505. Draeger Medical, Inc., Telford, due to Heating failure- The power board which controls the incubator heater may not regulate the temperature properly resulting in a high temperature alarm a. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MO, OH, PR
Page updated: Jan 10, 2026