Z-1051-2008

Draeger TI500. Isolette Infant Incubator. Catalog Number: MU20505. Draeger Medical, Inc., Telford, PA 18969

Name: Z-1051-2008 Draeger TI500. Isolette Infant Incubator. Catalog Number: MU20505. Draeger Medical, Inc., Telford, PA 18969
Creator: Draeger Medical, Inc.
Published: 2008-01-31
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2008-01-31 / Terminated / root cause: manufacturing process

FDA source

Draeger Medical, Inc. began a recall of Draeger TI500. Isolette Infant Incubator. Catalog Number: MU20505. Draeger Medical, Inc., Telford, PA 18969 on 2008-01-31. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1051-2008
Status: Terminated
Initiated: 2008-01-31
Posted: 2008-03-18
Terminated: 2008-05-08
Recalling firm: Draeger, Inc.
Product: Draeger TI500. Isolette Infant Incubator. Catalog Number: MU20505. Draeger Medical, Inc., Telford, PA 18969
Product code: FMZ Incubator, Neonatal
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.
Root cause tag: manufacturing process
FDA 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 [email protected].
Quantity in commerce: 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.
Product codes and lots: Serial Numbers: PK05967, PK05990, PK05973, PK05986, PK05987, PK05988, PK05962, PK05963, PK05964, PK05965, PK05989, PK05976, PK05972, LT05951, PK05968, LT05952, PK05969, and PK05974.

Product code FMZ

K941106Class IIModel Ti500 Isolette Infant IncubatorAir-Shields, Inc. / cleared 1994-06-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)