Recall Z-1134-2007 ยท DQK Computer, Diagnostic, Programmable
General Electric Medical Systems Information Technology
GE Healthcare Systems ComboLab System. Made up of both Mac-Lab System, Software Version 6.5 2021423-015 Revision D and CardioLab System, Software Version 6.5 2021423-016 Revision D. Electrophysiological data systems. GE Medical Systems, Information Technologies, Inc., 8200 West Tower Avenue, Milwaukee, WI 53223 USA
| Date | Aug 7, 2007 (initiated Feb 16, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| 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. |
| Quantity | 832 (409 US and 423 OUS) |
| Distribution | 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, P |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050093 | MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM Ge Medical Systems Information Technologies, May 13, 2005 |