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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 June 13, 2003
Date Posted July 29, 2003
Recall Status1 Terminated 3 on July 29, 2003
Recall Number Z-1064-03
Recall Event ID 26719
510(K)Number k020543  k020547  
Product Classification unknown device name - Product Code 80FMZ
Product Servo Controlled Oxygen System for Ohmeda''s Medical Giraffe OmniBed and Ohmeda''s Medical Girraffe Incubators
Code Information Giraffe OmniBeds (w/Servo O2 option): HEDF50041 - HEDF50076 HDGE50562 ¿ HDGE50567, HDGF54039,  HDGF54153 ¿ HDGF54155 HDGF54165 ¿ HDGF54167  Giraffe Incubators (w/Servo O2 option):  HDHE50160-HDHE50161,  HDHF50023-HDHF50024, HDHF50105, HDHF50109, HDHF50114, HDHF50227- HDHF50245, HDHF50278, HDHF50302, HDHF50304, HDHF50306, HDHF50309, HDHF50327-HDHF50328, HDHF50333-HDHF50343, HDHF53070, HDHF54046, HDHF54122, HDHF54131-HDHF54133, HDHF54135, HDHF54143-HDHF54145, HDHF54152-HDHF54155.    
Recalling Firm/
Ohmeda Medical, A division of Datex-Ohmeda, Inc.
8880 Gorman Road
Laurel MD 20723
For Additional Information Contact Alberto F. Profumo
Manufacturer Reason
for Recall
Firm's received complaints of medical device malfunction affecting instrument's calibration and alarm systems.
FDA Determined
Cause 2
Action Recalling firm notified foreign distributors and domestic consignees by e-mail and phone on 6/13/2003. Foreign regional distributors were requested to manage the recall. The notification described various instrument problems and remedial action available via the firm''s field action retrofit kits, #6600-0126-850 for the Giraffe OmniBed and #6600-0261-850 for the Giraffe Incubator.
Quantity in Commerce 157 units
Distribution Devices were sold to 15 international distributors and one domestic end user.

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 = 80FMZ and Original Applicant = OHMEDA MEDICAL