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GE Healthcare

185 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-03 recall (Z-1475-2026)GE Healthcare2026-02-27
GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; 2) 2066908- recall (Z-1483-2025)GE Healthcare2025-03-28
GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; recall (Z-1484-2025)GE Healthcare2025-03-28
GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 203390 recall (Z-1485-2025)GE Healthcare2025-03-28
GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 203 recall (Z-1486-2025)GE Healthcare2025-03-28
GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 20495 recall (Z-1487-2025)GE Healthcare2025-03-28
GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2089507-083, G recall (Z-0318-2025)GE Healthcare2024-11-07
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Number recall (Z-0039-2025)GE Healthcare2024-10-09
GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system. recall (Z-3214-2024)GE Healthcare2024-09-24
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344 recall (Z-3160-2024)GE Healthcare2024-09-17
Centricity Universal Viewer Workflow Manager, Image processing radiological system recall (Z-0142-2024)GE Healthcare2023-10-23
Universal Viewer Workflow Manager, Image processing radiological system recall (Z-0143-2024)GE Healthcare2023-10-23
Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Proce recall (Z-0138-2024)GE Healthcare2023-10-20
Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiol recall (Z-0139-2024)GE Healthcare2023-10-20
Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Ima recall (Z-0140-2024)GE Healthcare2023-10-20
Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-061, b) 206690 recall (Z-1500-2023)GE Healthcare2023-05-02
Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog Numbers: a) 20 recall (Z-1501-2023)GE Healthcare2023-05-02
Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2049587-009, d) recall (Z-1502-2023)GE Healthcare2023-05-02
The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient recall (Z-2872-2020)Ge Healthcare2020-08-27
GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 3.0T, Discovery M recall (Z-0254-2016)GE Healthcare2015-11-10
GE Healthcare, SIGNA 3.0T. Product Usage: Magnetic resonance system for diagnostic imaging recall (Z-0255-2016)GE Healthcare2015-11-10
GE Healthcare, SIGNA Excite 3.0T. MR System for use as a diagnostic imaging device. recall (Z-0256-2016)GE Healthcare2015-11-10
GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open recall (Z-0257-2016)GE Healthcare2015-11-10
GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a whole body m recall (Z-0258-2016)GE Healthcare2015-11-10
GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and 3.0T Signa HD recall (Z-0259-2016)GE Healthcare2015-11-10
GE Healthcare, SIGNA PET/MR 3.0T. Product Usage: The SIGNA PET/MR system combines magnetic recall (Z-0260-2016)GE Healthcare2015-11-10
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives me recall (Z-0023-2016)GE Healthcare2015-10-05
Lightspeed 16 CT recall (Z-2801-2015)GE Healthcare2015-09-21
PET Discovery LS recall (Z-2802-2015)GE Healthcare2015-09-21
PET Discovery ST 16 recall (Z-2803-2015)GE Healthcare2015-09-21
Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Univer recall (Z-2469-2015)GE Healthcare2015-08-27
Centricity Universal Viewer Product Usage: The Centricity Universal Viewer Version 6.0 sof recall (Z-2470-2015)GE Healthcare2015-08-27
GE Healthcare, Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed Plus; recall (Z-2339-2015)GE Healthcare2015-08-05
GE Healthcare Precision 500D Classical R & F system. recall (Z-2120-2015)GE Healthcare2015-07-20
GE Healthcare Precision RXi 23A/32A Analog System recall (Z-2121-2015)GE Healthcare2015-07-20
GE Healthcare Precision RXi Digital system recall (Z-2122-2015)GE Healthcare2015-07-20
GE Healthcare, Precision MPi fluoroscopic imaging systems. recall (Z-2123-2015)GE Healthcare2015-07-20
GE Healthcare Optima IGS 320. Angiographic X-ray systems used in generating fluoroscopic a recall (Z-1973-2015)GE Healthcare2015-07-03
GE Healthcare Discovery IGS 730. Angiographic X-ray systems used in generating fluoroscopi recall (Z-1974-2015)GE Healthcare2015-07-03
GE Healthcare Discovery IGS 740 & GE Healthcare Innova IGS 740. Angiographic X-ray systems recall (Z-1975-2015)GE Healthcare2015-07-03
GE Healthcare Innova 2100IQ. Angiographic X-ray systems used in generating fluoroscopic an recall (Z-1976-2015)GE Healthcare2015-07-03
GE Healthcare Innova 2121IQ. Angiographic X-ray systems used in generating fluoroscopic an recall (Z-1977-2015)GE Healthcare2015-07-03
GE Healthcare Innova 3100IQ. Angiographic X-ray systems used in generating fluoroscopic an recall (Z-1978-2015)GE Healthcare2015-07-03
GE Healthcare Innova 3131IQ. Angiographic X-ray systems used in generating fluoroscopic an recall (Z-1979-2015)GE Healthcare2015-07-03
GE Healthcare Innova IGS 520. Angiographic X-ray systems used in generating fluoroscopic a recall (Z-1980-2015)GE Healthcare2015-07-03
GE Healthcare Innova IGS 530. Angiographic X-ray systems used in generating fluoroscopic a recall (Z-1981-2015)GE Healthcare2015-07-03
GE Healthcare Innova IGS 540. Angiographic X-ray systems used in generating fluoroscopic a recall (Z-1982-2015)GE Healthcare2015-07-03
GE Healthcare Innova IGS 620. Angiographic X-ray systems used in generating fluoroscopic a recall (Z-1983-2015)GE Healthcare2015-07-03
GE Healthcare Innova IGS 630. Angiographic X-ray systems used in generating fluoroscopic a recall (Z-1984-2015)GE Healthcare2015-07-03
GE Healthcare Optima CL 323i. Angiographic X-ray systems used in generating fluoroscopic a recall (Z-1985-2015)GE Healthcare2015-07-03
GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Sys recall (Z-1966-2015)GE Healthcare2015-07-02
GE Healthcare, Treadmill T2100. For Exercise Testing, facilitating accurate blood pressure recall (Z-1825-2015)GE Healthcare2015-06-22
D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with Compact Airwa recall (Z-1680-2015)GE Healthcare2015-05-28
CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designed to be a head a recall (Z-1623-2015)GE Healthcare2015-05-15
GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50). recall (Z-1606-2015)GE Healthcare2015-05-12
GE Discovery MR950 MRI system recall (Z-1395-2015)GE Healthcare2015-05-01
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx recall (Z-1405-2015)GE Healthcare2015-04-27
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx recall (Z-1406-2015)GE Healthcare2015-04-27
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx recall (Z-1407-2015)GE Healthcare2015-04-27
Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray recall (Z-1441-2015)GE Healthcare2015-04-13
GE Healthcare, Aespire 7900, Aespire View Anesthesia Machines. Model numbers 1009-9012-000 recall (Z-1376-2015)GE Healthcare2015-04-02
GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers 1505- recall (Z-1270-2015)GE Healthcare2015-03-24
GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EX recall (Z-1305-2015)GE Healthcare2015-03-20
GE Healthcare, Treadmill T2100 and Treadmill T2000 with power cord part numbers 408930-001 recall (Z-1285-2015)GE Healthcare2015-03-17
GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all config recall (Z-1279-2015)GE Healthcare2015-03-13
GE Healthcare Proteus XR/a with wall stand model number 2260354. Intended for use in gener recall (Z-1248-2015)GE Healthcare2015-03-06
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis t recall (Z-1214-2015)GE Healthcare2015-02-26
This correction applies to all GE Healthcare MRI systems with superconducting magnets: Dis recall (Z-1035-2015)GE Healthcare2015-02-18
The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, p recall (Z-0955-2015)GE Healthcare2015-01-26
GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner. recall (Z-0985-2015)GE Healthcare2015-01-15
GE Healthcare, Discovery IGS 730 & Discovery IGS 740. Discovery IGS 730 : The angiographic recall (Z-0966-2015)GE Healthcare2015-01-14
GE Healthcare, Proteus XR/a with wall stand model number 600-0301. recall (Z-0954-2015)GE Healthcare2015-01-12
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis t recall (Z-1665-2014)GE Healthcare2014-05-28
Giraffe Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates recall (Z-1547-2014)GE Healthcare2014-05-06
Panda iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonat recall (Z-1548-2014)GE Healthcare2014-05-06
Panda Freestanding Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat recall (Z-1549-2014)GE Healthcare2014-05-06
Panda Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to recall (Z-1550-2014)GE Healthcare2014-05-06
Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part manufactur recall (Z-1551-2014)GE Healthcare2014-05-06
Giraffe Infant Warmers, part number M1118179, labeled in part *** GE Healthcare 8880 Gorma recall (Z-0912-2014)GE Healthcare2014-02-03
Panda iRes Infant Warmers, part number M1112198 and Panda Freestanding Warmers, part numbe recall (Z-0913-2014)GE Healthcare2014-02-03
Stand-Alone Resuscitation Unit, Bag and Mask, part number M1226444, labeled in part ***GE recall (Z-0914-2014)GE Healthcare2014-02-03
Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139612, labeled recall (Z-0915-2014)GE Healthcare2014-02-03
Stand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 2063773-001, 20 recall (Z-0916-2014)GE Healthcare2014-02-03
Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628, labeled recall (Z-0917-2014)GE Healthcare2014-02-03
Discovery CT 750 HD model numbers: 5232083, 5232083-2, 5232083-3, and 5232083-4. For head, recall (Z-0668-2010)Ge Healthcare2010-02-02
LightSpeed VCT 7.2 Vision model numbers: 5212920-300 console used with 5129909, 5129909-5, recall (Z-0669-2010)Ge Healthcare2010-02-02
iDXA, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, recall (Z-0600-2010)Ge Healthcare2010-01-27
Prodigy 1-8 series, GE Lunar DEXA bone densitometers operating with enCORE software versio recall (Z-0601-2010)Ge Healthcare2010-01-27
DPX-NT series, GE Lunar DEXA bone densitometers operating with enCORE software versions 12 recall (Z-0602-2010)Ge Healthcare2010-01-27
DPX-MD series, GE Lunar DEXA bone densitometers operating with enCORE software versions 12 recall (Z-0603-2010)Ge Healthcare2010-01-27
DPX-Bravo/Duo, GE Lunar DEXA bone densitometers operating with enCORE software versions 12 recall (Z-0604-2010)Ge Healthcare2010-01-27
GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy. recall (Z-0004-2010)Ge Healthcare2010-01-20
GE OEC 9900 Elite GSP Fluoroscopes To produce mobile fluoroscopic images of human anatomy. recall (Z-0005-2010)Ge Healthcare2010-01-20
GE Healthcare Fluorostar 7900 Mobile Fluoroscopy System recall (Z-1155-2009)Ge Healthcare2009-09-24
GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha, W recall (Z-1687-2009)Ge Healthcare2009-09-24
GE Innova 3100, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The syst recall (Z-1688-2009)Ge Healthcare2009-09-24
GE Innova 3100-IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The s recall (Z-1689-2009)Ge Healthcare2009-09-24
GE Innova 4100, GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane recall (Z-1690-2009)Ge Healthcare2009-09-24
GE Innova 4100-IQ, GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monopla recall (Z-1691-2009)Ge Healthcare2009-09-24
GE Datex-Ohmeda ADU Carestation Intended to provide general inhalation anesthesia and vent recall (Z-1633-2009)GE Healthcare2009-07-30
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