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U.S. Department of Health and Human Services

Class 2 Device Recall TI500 Isolette Infant Incubator

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 Class 2 Device Recall TI500 Isolette Infant Incubatorsee related information
Date Initiated by FirmJanuary 31, 2008
Date PostedMarch 18, 2008
Recall Status1 Terminated 3 on May 08, 2008
Recall NumberZ-1051-2008
Recall Event ID 46742
510(K)NumberK941106 
Product Classification Neonatal Incubator - Product Code FMZ
ProductDraeger TI500. Isolette Infant Incubator. Catalog Number: MU20505. Draeger Medical, Inc., Telford, PA 18969
Code Information Serial Numbers: PK05967, PK05990, PK05973, PK05986, PK05987, PK05988, PK05962, PK05963, PK05964, PK05965, PK05989, PK05976, PK05972, LT05951, PK05968, LT05952, PK05969, and PK05974.
FEI Number 2517967
Recalling Firm/
Manufacturer		 Draeger Medical, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information ContactKathy Anderson
215-721-5400
Manufacturer 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 2		Nonconforming Material/Component
ActionThe 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.
Quantity in Commerce18 units
DistributionWorldwide Distribution-- USA including states MO, OH, and PR, and countries of Australia, Canada, Columbia, Israel, UAE, France, China, Italy, Denmark, Switzerland, and UK.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FMZ
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