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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 October 17, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on October 11, 2005
Recall Number Z-0288-04
Recall Event ID 27490
510(K)Number k020543  
Product Classification Incubator, Neonatal - Product Code FMZ
Product Radiant Heater Door Vent for Ohmeda Medical''s Giraffe (tm) OmniBed neonate bed.
Code Information HDGDyyyyy HDGEyyyyy HDGFyyyyy HDGGyyyyy where ''yyyyy'' represents any number less than 60000 
Recalling Firm/
Manufacturer		 Ohmeda Medical, A Div of Datex-Ohmeda , Inc
8880 Gorman Rd
Laurel MD 20723-5800
For Additional Information Contact Alberto Profumo
410-888-5204
Manufacturer Reason
for Recall		 Heater vent door on neonatal incubator may malfunction.
FDA Determined
Cause 2		 Other
Action The recalling firm notified domestic consignees by certified letter and international distributors by e-mail dated 10/17/2003. The recall notice was incorporated into a firm''s follow-up letter concerning an on-going product correction of the elevating base on the same neonatal beds. The letter advises of the malfunctioning heater door vent and states that the firm will replace all existing vent doors with doors made of higher temperature rated material. Firm will provide retrofit kits for consignee or service representative installation.
Quantity in Commerce 1404 beds
Distribution Products were sold to 365 direct accounts around the US and 58 international 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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