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General Electric Medical Systems Information Technology

15 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
GE ApexPro Oximeter systems (ApexPro CH or ApexPro FH with ApexPro Telemetry version 3.9 s recall (Z-0631-2010)General Electric Medical Systems Information Technology2010-01-13
GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. recall (Z-0280-2008)General Electric Medical Systems Information Technology2008-02-01
GE Medical Systems Information Technologies Clinical Information Center (CIC) Pro v5.0.3 & recall (Z-0519-2008)General Electric Medical Systems Information Technology2008-01-17
GE Medical Systems Mac-Lab System, cardiac catheterization data system. Software Version 6 recall (Z-1132-2007)General Electric Medical Systems Information Technology2007-08-07
GE Medical Systems CardioLab System, electrophysiological data system, Software Version 6. recall (Z-1133-2007)General Electric Medical Systems Information Technology2007-08-07
GE Healthcare Systems ComboLab System. Made up of both Mac-Lab System, Software Version 6. recall (Z-1134-2007)General Electric Medical Systems Information Technology2007-08-07
GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. recall (Z-0891-2007)General Electric Medical Systems Information Technology2007-06-06
GE CIC Central Station Monitoring Product, Versions 3.x, 4.0.5, 4.0.6 recall (Z-0030-05)General Electric Medical Systems Information Technology2004-10-21
PatientNet Monitoring System - PatientNet Central Stations utilizing software Versions 1.0 recall (Z-0727-04)General Electric Medical Systems Information Technology2004-07-20
Solar 9500 Information Monitor with software version 3A. recall (Z-0250-04)General Electric Medical Systems Information Technology2003-12-18
Solar 8000M Patient Monitor with software versions 3A, 3B and 3C recall (Z-0092-04)General Electric Medical Systems Information Technology2003-11-06
MAC-LAB 1000EX systems recall (Z-0783-03)General Electric Medical Systems Information Technology2003-04-25
MAC-LAB 3000EX systems recall (Z-0784-03)General Electric Medical Systems Information Technology2003-04-25
MAC-LAB 5000EX systems recall (Z-0785-03)General Electric Medical Systems Information Technology2003-04-25
MAC-LAB (Classic) systems recall (Z-0786-03)General Electric Medical Systems Information Technology2003-04-25

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Every clearance here is in the API, with alerts when new ones post.