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Devices
Device Recall TI500 Isolette Infant Incubator
Model / Serial
Serial Numbers: PK05967, PK05990, PK05973, PK05986, PK05987, PK05988, PK05962, PK05963, PK05964, PK05965, PK05989, PK05976, PK05972, LT05951, PK05968, LT05952, PK05969, and PK05974.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
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 Description
Draeger TI500. Isolette Infant Incubator. Catalog Number: MU20505. Draeger Medical, Inc., Telford, PA 18969
Manufacturer
Draeger Medical, Inc.
1 Event
Recall of Device Recall TI500 Isolette Infant Incubator
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Manufacturer
Draeger Medical, Inc.
Manufacturer Address
Draeger Medical, Inc., 3135 Quarry Rd, Telford PA 18969-1042
Manufacturer Parent Company (2017)
Stefan Dräger GmbH
Source
USFDA
Language
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