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U.S. Department of Health and Human Services

Class 2 Device Recall GE Centricity Ultra Laboratory System

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  Class 2 Device Recall GE Centricity Ultra Laboratory System see related information
Date Initiated by Firm September 22, 2008
Date Posted December 31, 2008
Recall Status1 Terminated 3 on May 18, 2010
Recall Number Z-0472-2009
Recall Event ID 49517
Product Classification Calculator/Data Processing Module for Clinical Use - Product Code JQP
Product GE Centricity Ultra Laboratory System Software; for recording, reporting and distribution of lab results. GE Healthcare Integrated IT Solutions, Barrington, IL 60010.
Code Information Software versions 3.3.2.27_P4 and 4.0.1_SP.x
Recalling Firm/
Manufacturer		 GE Healthcare Integrated IT Solutions
540 W Northwest Hwy
Barrington IL 60010-3051
For Additional Information Contact GE Customer Care Center
800-437-1171
Manufacturer Reason
for Recall		 Software computer, error: The abnormal result flag is not being sent in the HL7 messages on results that are lower than the normal range. For further information, please telephone GE Healthcare Integrated IT Solutions at 800-437-1171.
FDA Determined
Cause 2		 Software design
Action GE Healthcare notified their Centricity Ultra Laboratory Information System customers via letter dated 9/19/08. The letter was entitled "PRODUCT SAFETY NOTIFICATION." The letter states that the software correction was installed or will be installed to correct the abnormal results flag not being sent in the HL7 on results that are lower than the normal range. The letter summarized the safety concern and the action taken. Any questions were directed to GE Technical Support at 888-778-3373 or 905-479-1249. The accounts were requested to complete the enclosed customer reply form, supplying the software version number, and fax it back to 847-277-5240.
Quantity in Commerce 3 units
Distribution Globally - United States including the states of New York and Texas; and the country of Canada.
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.
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