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GE Healthcare LLC

397 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE recall (Z-2116-2013)GE Healthcare, LLC2013-08-28
GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module recall (Z-2117-2013)GE Healthcare, LLC2013-08-28
GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be used in medical prac recall (Z-2098-2013)GE Healthcare, LLC2013-08-27
The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybrid system is a co recall (Z-1967-2013)GE Healthcare, LLC2013-08-20
GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform rad recall (Z-1989-2013)GE Healthcare, LLC2013-08-20
GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is inte recall (Z-1940-2013)GE Healthcare, LLC2013-08-09
GE Healthcare, Optima XR220amx, Optima XR200amx, and Brivo XR285amx. The series are indica recall (Z-1942-2013)GE Healthcare, LLC2013-08-09
SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCI recall (Z-1943-2013)GE Healthcare, LLC2013-08-09
GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use by a qualified ph recall (Z-1944-2013)GE Healthcare, LLC2013-08-09
GE Healthcare, LOGIQ e Ultrasound System. The LOGIQ i/e and Vivid e is a general purpose u recall (Z-1849-2013)GE Healthcare, LLC2013-08-01
GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM. The device is recall (Z-1833-2013)GE Healthcare, LLC2013-07-31
GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye recall (Z-1787-2013)GE Healthcare, LLC2013-07-24
GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Qua recall (Z-1788-2013)GE Healthcare, LLC2013-07-24
Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usag recall (Z-1789-2013)GE Healthcare, LLC2013-07-24
Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Product recall (Z-1790-2013)GE Healthcare, LLC2013-07-24
Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Product U recall (Z-1791-2013)GE Healthcare, LLC2013-07-24
Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Product recall (Z-1792-2013)GE Healthcare, LLC2013-07-24
Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuc recall (Z-1793-2013)GE Healthcare, LLC2013-07-24
GE Healthcare, Innova 3100 and Innova 4100 systems. The Digital Fluoroscopic Imaging Syste recall (Z-1616-2013)GE Healthcare, LLC2013-06-28
GE Healthcare Senographe Essential System. The Senographe 2000D system generates digital m recall (Z-1519-2013)GE Healthcare, LLC2013-06-26
CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is a multi-parameter h recall (Z-1567-2013)GE Healthcare, LLC2013-06-21
GE Healthcare, PET VCAR. PET VCAR application software is affected if installed on any of recall (Z-1551-2013)GE Healthcare, LLC2013-06-18
Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M1084850. Int recall (Z-1443-2013)GE Healthcare, LLC2013-06-03
GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 recall (Z-1318-2013)GE Healthcare, LLC2013-05-14
GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa H recall (Z-1207-2013)GE Healthcare, LLC2013-05-01
GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnostic imaging devi recall (Z-1208-2013)GE Healthcare, LLC2013-05-01
GE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR System, GE 0. recall (Z-1209-2013)GE Healthcare, LLC2013-05-01
MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic imaging device t recall (Z-1211-2013)GE Healthcare, LLC2013-05-01
Optima MR430s MRI Scanner; 5000-0002 is indicated to use as a magnetic resonance imaging d recall (Z-1212-2013)GE Healthcare, LLC2013-05-01
GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Dis recall (Z-1188-2013)GE Healthcare, LLC2013-04-29
Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models H3000ZW & H3 recall (Z-1168-2013)GE Healthcare, LLC2013-04-24
GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, processing, archivi recall (Z-1164-2013)GE Healthcare, LLC2013-04-23
GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventio recall (Z-1142-2013)GE Healthcare, LLC2013-04-18
GE Healthcare Muse v7 cardiology information system. Model number 2026443-001: MUSE 7.0 ap recall (Z-1133-2013)GE Healthcare, LLC2013-04-17
GE Healthcare, AW Server. Product Usage: . AW Server is a medical software system that all recall (Z-1137-2013)GE Healthcare, LLC2013-04-17
GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ S7 (with soft recall (Z-1096-2013)GE Healthcare, LLC2013-04-11
GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293. Product Usage: It is in recall (Z-1100-2013)GE Healthcare, LLC2013-04-11
GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual recall (Z-1078-2013)GE Healthcare, LLC2013-04-10
VMX, VMX Plus Mobile Radiographic Unit with the following models: 45296139; 45296200; 4529 recall (Z-1083-2013)GE Healthcare, LLC2013-04-10
Giraffe OmniBed and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: *** recall (Z-1051-2013)GE Healthcare, LLC2013-04-05
GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova3100IQ, and recall (Z-0947-2013)GE Healthcare, LLC2013-03-13
GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular X-ray imagin recall (Z-0934-2013)GE Healthcare, LLC2013-03-11
Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa V recall (Z-0935-2013)GE Healthcare, LLC2013-03-11
GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advant recall (Z-0901-2013)GE Healthcare, LLC2013-03-01
GE Healthcare Definium 5000 / 5220493 X-Ray System recall (Z-0703-2013)GE Healthcare, LLC2013-02-27
GE Healthcare Definium 5000/5220493-2 X-Ray System recall (Z-0704-2013)GE Healthcare, LLC2013-02-27
GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System recall (Z-0761-2013)GE Healthcare, LLC2013-02-26
GE Healthcare, Dash Port 2 Docking Station. Product Usage: is a docking station (quick mou recall (Z-0814-2013)GE Healthcare, LLC2013-02-14
GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter pat recall (Z-0823-2013)GE Healthcare, LLC2013-02-14
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor and access recall (Z-0813-2013)GE Healthcare, LLC2013-02-13
GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece Resuscitation S recall (Z-0748-2013)GE Healthcare, LLC2013-02-08
Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitation System [vent recall (Z-0749-2013)GE Healthcare, LLC2013-02-08
AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7 recall (Z-0754-2013)GE Healthcare, LLC2013-01-30
GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circ recall (Z-0606-2013)GE Healthcare, LLC2012-12-26
Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 and 3.1 (versi recall (Z-0560-2013)GE Healthcare, LLC2012-12-19
GE Healthcare, Dash 3000/4000/5000. The Dash 3000/4000/5000 patient monitor is intended fo recall (Z-0494-2013)GE Healthcare, LLC2012-12-16
GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Tr recall (Z-0524-2013)GE Healthcare, LLC2012-12-14
GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX recall (Z-0448-2013)GE Healthcare, LLC2012-11-29
GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic Mobile X-Ray (AMX recall (Z-0449-2013)GE Healthcare, LLC2012-11-29
GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mobile X-Ray (AMX) recall (Z-0450-2013)GE Healthcare, LLC2012-11-29
GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic im recall (Z-0197-2013)GE Healthcare, LLC2012-11-16
GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging of the human he recall (Z-0198-2013)GE Healthcare, LLC2012-11-16
GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of the human head recall (Z-0199-2013)GE Healthcare, LLC2012-11-16
GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head a recall (Z-0200-2013)GE Healthcare, LLC2012-11-16
GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A med recall (Z-0125-2013)GE Healthcare, LLC2012-10-24
GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical tool intended for use recall (Z-0121-2013)GE Healthcare, LLC2012-10-23
GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advantage 1.x, Seno Adv recall (Z-0095-2013)GE Healthcare, LLC2012-10-19
GE Healthcare innova 3100, Mobile X-ray system. The innova systems are indicated for use i recall (Z-0113-2013)GE Healthcare, LLC2012-10-17
GE Healthcare innova 3100-IQ, Mobile X-ray system The innova systems are indicated for use recall (Z-0114-2013)GE Healthcare, LLC2012-10-17
GE Healthcare innova 3131-IQ Mobile X-ray system. The innova systems are indicated for use recall (Z-0115-2013)GE Healthcare, LLC2012-10-17
Optima XR220amx Mobile general purpose radiographic imaging of the human head and body. recall (Z-2255-2012)GE Healthcare, LLC2012-09-13
Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body. recall (Z-2256-2012)GE Healthcare, LLC2012-09-13
GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: recall (Z-2376-2012)GE Healthcare, LLC2012-09-13
GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume recall (Z-2203-2012)GE Healthcare, LLC2012-08-13
GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are recall (Z-1993-2012)GE Healthcare, LLC2012-07-19
GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 2016995-001, 201699 recall (Z-2015-2012)GE Healthcare, LLC2012-07-16
GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonogra recall (Z-1960-2012)GE Healthcare, LLC2012-07-09
GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/ recall (Z-1787-2012)GE Healthcare, LLC2012-06-17
GE Healthcare, Optima MR450W with GEM. Product Usage - The GEM Option for 1 .5T MRI system recall (Z-1492-2012)GE Healthcare, LLC2012-05-04
GE Healthcare Automatic Mobile X- Ray (AMX) series: Brivo XR285 15KW, Brivo XR285 30KW, Op recall (Z-1399-2012)GE Healthcare, LLC2012-04-24
GE Healthcare Innova X-ray Imaging Systems. The Digital Fluoroscopic Imaging System is ind recall (Z-1124-2012)GE Healthcare, LLC2012-03-19
GE Discovery NM/CT 670 The GE Discovery NM/CT 670 system is a medical tool intended for us recall (Z-1110-2012)GE Healthcare, LLC2012-02-27
GE Discovery NM 630 The GE Discovery NM 630 system is a medical tool intended for use by a recall (Z-1111-2012)GE Healthcare, LLC2012-02-27
GE Healthcare, LOGIQ S8 DIAGNOSTIC ULTRASOUND SYSTEM with R1.1.0 Software. Intended for us recall (Z-1093-2012)GE Healthcare, LLC2012-02-23
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS The Revolution XR/d recall (Z-1065-2012)GE Healthcare, LLC2012-02-21
GE SIGNA EXCITE MR SURGICAL OPTION (MR450w Surgical Suite). The MR Surgical Option when in recall (Z-1067-2012)GE Healthcare, LLC2012-02-21
GE SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM ( SENO 2000D). The Senographe 20 recall (Z-1063-2012)GE Healthcare, LLC2012-02-20
GE eXplore Locus Micro CT cabinet x-ray system model RS9-80. CT Scanner for laboratory mic recall (Z-0833-2012)GE Healthcare, LLC2012-02-17
GE Healthcare Signa, Discovery and Optima. Signa HDe 1.5T; Signa Infinity TwinSpeed MR Sys recall (Z-0148-2012)GE Healthcare, LLC2012-02-08
GE LOGIQ P6 Ultrasound System. The device is intended for use by a qualified physician for recall (Z-0834-2012)GE Healthcare, LLC2012-01-21
GE Healthcare AW Server version 2.0 with release 2.0 - 4.0 A medical software system that recall (Z-0486-2012)GE Healthcare, LLC2012-01-11
GE Healthcare Definium 8000, Digital Radiographic Systems. Revolution XR/d Digital Radiogr recall (Z-0584-2012)GE Healthcare, LLC2012-01-11
GE Healthcare Discovery XR650, Digital Radiographic Systems. Revolution XR/d Digital Radio recall (Z-0585-2012)GE Healthcare, LLC2012-01-11
GE LOGIQ E9 Diagnostic Ultrasound Systems running software versions R3.1.0 and R3.1.1. The recall (Z-0705-2012)GE Healthcare, LLC2012-01-11
GE Healthcare, Innova 3100IQ (Optima Edition) Fluoroscopic Vascular X-ray System. Indicate recall (Z-0133-2012)GE Healthcare, LLC2011-10-28
GE HEALTHCARE, MSK 1.5T EXTREME MR SCANNER, MODEL AA5000. The MSK Extreme TM MR Scanner is recall (Z-0107-2012)GE Healthcare, LLC2011-10-26
GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM (SENO ESSENTIAL). The Senographe Ess recall (Z-0114-2012)GE Healthcare, LLC2011-10-26
GE SENOGRAPHE DS FULL FIELD DIGITAL ESSENTIAL MAMMOGRAPHY SYSTEM. The Senographe DS system recall (Z-0115-2012)GE Healthcare, LLC2011-10-26
ADVANTAGE WINDOWS (Workstation) WITH FUNCTOOL OPTION GE Medical Systems, SCS. A software m recall (Z-3282-2011)GE Healthcare, LLC2011-09-27
DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 (GE Healthcare) recall (Z-3206-2011)GE Healthcare, LLC2011-09-14
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