Date Initiated by Firm | June 20, 2008 |
Date Posted | November 21, 2008 |
Recall Status1 |
Terminated 3 on March 24, 2010 |
Recall Number | Z-0305-2009 |
Recall Event ID |
49097 |
Product Classification |
Neonatal lncubator. - Product Code FMZ
|
Product | Giraffe OmniBed, labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***.
The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user's demand. |
Code Information |
All lots. |
Recalling Firm/ Manufacturer |
Datex Ohmeda, Inc. dba GE Healthcare 8880 Gorman Rd Laurel MD 20723-5800
|
For Additional Information Contact | Ann M. Lebar 410-888-5200 |
Manufacturer Reason for Recall | Manufacturer of neonatal incubators changed the device labeling to account for new use and care instructions. |
FDA Determined Cause 2 | Equipment maintenance |
Action | A notification letter (Urgent Medical Device Correction) was sent to consignees on 06/20/08. The notification letter addressed healthcare professionals, including neonatal, infection control and nursing departments at medical facilities. In add tion, the letter advised of revisions to the current Giraffe OmniBed cleaning instructions contained in the product Operators Manual. Instructions were enclosed with the notification letter and are intended to supplement those already present in the manual.
Contact the GE Healthcare Technical Support center at 1-800-558-7044 for questions or additional information. If outside of the USA, please contact your local GE Healthcare Service Representative. |
Quantity in Commerce | 7,878 beds |
Distribution | Worldwide Distribution: The devices were widely distributed to national and international medical facilities. |
Total Product Life Cycle | TPLC Device Report |
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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.
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