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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmJune 13, 2003
Date PostedJuly 29, 2003
Recall Status1 Terminated 3 on July 29, 2003
Recall NumberZ-1064-03
Recall Event ID 26719
510(K)NumberK020543 K020547 
Product Classification unknown device name - Product Code 80FMZ
ProductServo 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/
Manufacturer		 Ohmeda Medical, A division of Datex-Ohmeda, Inc.
8880 Gorman Road
Laurel MD 20723
For Additional Information ContactAlberto F. Profumo
410-888-5204
Manufacturer Reason
for Recall		Firm's received complaints of medical device malfunction affecting instrument's calibration and alarm systems.
FDA Determined
Cause 2		Other
ActionRecalling 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 Commerce157 units
DistributionDevices 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) Database510(K)s with Product Code = 80FMZ
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