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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm April 25, 2005
Date Posted July 28, 2005
Recall Status1 Terminated 3 on January 11, 2007
Recall Number Z-1047-05
Recall Event ID 31665
510(K)Number k993407  k020543  k010222  k020547  
Product Classification Incubator, Neonatal - Product Code FMZ
Product Ohmeda Medical''s Giraffe¿ OmniBeds¿ and Giraffe Incubators
Code Information Serial Numbers: HDHE50001 to HDHE50164; HDHF50001 to HDHF50357; HDHF52001 to HDHF52212; HDHF53001 to HDHF53156; HDHF54001 to HDHF54168; HDHG54001 to HDHG54320; HDGD50200 to HDGD50389; HDGE50001 to HDGE50591; HDGF50001 to HDGF50046; HDGF52001 to HDGF52036; HDGF53001 to HDGF53102; HDGF54001 to HDGF54190; HDGG54001 to HDGG54367
Recalling Firm/
Manufacturer		 Ohmeda Medical, A division of Datex-Ohmeda, Inc.
8880 Gorman Rd
Laurel MD 20723-5800
For Additional Information Contact Gary Mullenbach
800-345-2700 Ext. 3583
Manufacturer Reason
for Recall		 Neonatal incubators and beds may unintentionally move from a safe position following an interruption in the power supply.
FDA Determined
Cause 2		 Other
Action Ohmeda Medical notified consignees 04/25/05 by letter flagged as an 'Urgent Medical Device Correction'. The serial number specific notification advised that the elevating base may move following the mains power interruption. The letter further advised that the notice should not be confused with a previous (medical device correction) letter sent concerning movement of the elevating base caused by the footswitches on the device. Ohmeda indicated in the letter that users may continue to use the device with stated precautions, pending hardware upgrade by the firm''s service technologists.
Quantity in Commerce 1674 devices
Distribution The incubators were distributed to hospital neonatal intensive care centers across the US. The devices were additionally distributed to international subsidiaries and distributors.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = FMZ and Original Applicant = OHMEDA MEDICAL
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