GE Medical Systems China Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
26 (18 Class I)
510(k) Clearances
12
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0913-2026Class IGE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, November 14, 2025
Z-0915-2026Class IGE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRUNovember 14, 2025
Z-0914-2026Class IGE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, November 14, 2025
Z-2029-2025Class IIGE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound systMay 16, 2025
Z-2030-2025Class IIGE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: May 16, 2025
Z-1629-2025Class IGE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002March 21, 2025
Z-1626-2025Class IGE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012March 21, 2025
Z-1628-2025Class IGE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000March 21, 2025
Z-1632-2025Class IGE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000March 21, 2025
Z-1637-2025Class IGE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000March 21, 2025
Z-1627-2025Class IGE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200March 21, 2025
Z-1638-2025Class IGE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002March 21, 2025
Z-1624-2025Class IGE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000March 21, 2025
Z-1631-2025Class IGE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200March 21, 2025
Z-1636-2025Class IGE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002March 21, 2025
Z-1634-2025Class IGE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200March 21, 2025
Z-1625-2025Class IGE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002March 21, 2025
Z-1633-2025Class IGE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002March 21, 2025
Z-1635-2025Class IGE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000March 21, 2025
Z-1630-2025Class IGE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012March 21, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K151063Monitor B40December 15, 2015
K142288MAC 800 Resting ECG Analysis SystemDecember 3, 2014
K133576MONITOR B40February 21, 2014
K130584MONITOR B40June 26, 2013
K122253PROCARE MONITOR B20March 22, 2013
K123238ACHILLESFebruary 25, 2013
K120598PROCARE MONITOR B40July 19, 2012
K103633ACHILLESMay 11, 2011
K102256GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUNDOctober 5, 2010
K102113GE VENUE 40 COMPACT DIAGNOSTIC ULTRASOUNDAugust 12, 2010
K091374GE LOGIQ I/E & VIVID E COMPACT ULTRASOUNDMay 26, 2009
K091164GE VENUE 40, MODEL 5324338May 5, 2009