|
Class 2 Device Recall |
|
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/ Manufacturer |
Ohmeda Medical, A division of Datex-Ohmeda, Inc. 8880 Gorman Road Laurel MD 20723
|
For Additional Information Contact |
Alberto 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 |
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
|
|
|
|