Ge Healthcare It

FDA Regulatory Profile

Summary

Total Recalls
17
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0748-2014Class IIMerge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imagingAugust 26, 2013
Z-0116-2014Class IIThe Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diJune 11, 2013
Z-0833-2015Class IICentricity Enterprise Archive is a software product for receiving, archiving and sending of medical April 19, 2013
Z-0330-2014Class IIThe Centricity Laboratory System is intended to be an information system designed to support the cliMarch 12, 2013
Z-0620-2014Class IIThe Centricity Laboratory System is intended to be an information system designed to support the cliMarch 12, 2013
Z-0337-2014Class IICentricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments heMarch 11, 2013
Z-2300-2016Class IIImagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is aFebruary 18, 2013
Z-0865-2014Class IIIThe Centricity Laboratory System is intended to be an information system designed to support the cliNovember 20, 2012
Z-2671-2016Class IICentricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is intended to be an iNovember 20, 2012
Z-1585-2013Class IIThe Centricity Laboratory System is intended to be an information system designed to support the cliNovember 20, 2012
Z-2739-2016Class IICentricity Enterprise Archive is a software product for receiving, archiving and sending of medical November 16, 2012
Z-2579-2016Class IIGE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and CommunicatiNovember 15, 2012
Z-0034-2014Class IICentricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). October 2, 2012
Z-0731-2014Class IICentricity PACS System versions 3.X and higher and 4.X and higher Product Usage: The Centricity PASeptember 15, 2012
Z-0118-2014Class IICentricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical imagJune 15, 2012
Z-0454-2014Class IIThe GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a April 19, 2012
Z-0773-2014Class IIImagecast PACS is an image management system intended to be used by trained professionals, includingMarch 4, 2011