GE Medical Systems CardioLab System, electrophysiological data system, Software Version 6.5 2021423-016 Revision D GE Medical Systems, Information Technologies, Inc. 8200 West Tower Avenue, Milwaukee, WI 53223 USA.
FDA Recall Z-1133-2007 · Posted 2007-08-07
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Recalling FirmGeneral Electric Medical Systems Information Technology
Recall StatusTerminated
Product CodeDQK
Date Initiated2007-02-16
Date Terminated2011-12-11
Product Quantity564 (285 US and 279 OUS)
Reason for Recall
GE Healthcare has identified conditions that could cause a potential loss of real-time monitoring with the CardioLab/Mac-Lab/ComboLab Electrophysiology and Hemodynamic Monitoring Systems. These issues are associated with an audio driver, and the use of the application's log and imaging windows.
Firm Action
Consignees were sent a letter dated 2/16/07. The letter described the product and problem, made recommendations and gave information on software update.
Root Cause
Other
Distribution Pattern
Worldwide, including USA, Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Republic of Korea, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Pakistan, Panama, Puerto Rico, Saudi Arabia, Singapore, South Africa, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Kingdom, and Venezuela.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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