Atlas FDA

GE Healthcare LLC

397 FDA 510(k) clearances · Recalling firm

Sort:Newest firstOldest first

◉ Watch GE Healthcare LLC

RecordFirmDate
GE Healthcare, 1.5T Optima MR450w Product Usage: The Optima MR450w is a whole body magneti recall (Z-3121-2011)GE Healthcare, LLC2011-09-01
GE Healthcare, 3.0T Signa MR750 (Marketing Name: GE Discovery MR750) Product Usage: The GE recall (Z-3122-2011)GE Healthcare, LLC2011-09-01
GE Healthcare, Discovery MR450 Product Usage: The Discovery MR450w is a whole body magneti recall (Z-3123-2011)GE Healthcare, LLC2011-09-01
GE Healthcare, DASH 3000, 4000, 5000 Patient Monitors The Dash 3000/4000/5000 patient moni recall (Z-3075-2011)GE Healthcare, LLC2011-08-25
GE Healthcare, Seno Advantage 2.1 and 2.2 Workstations with RIS CCOW integration, GE Healt recall (Z-3012-2011)GE Healthcare, LLC2011-08-12
GE Healthcare DISCOVERY MODEL NM/CT 670 NM/CT system recall (Z-2158-2011)GE Healthcare, LLC2011-07-21
Infusable and Infusa Scan Single Patient Use Pressure Infusors; Vital Signs Inc. A pressur recall (Z-2663-2011)GE Healthcare, LLC2011-06-24
Cuffable Blood Pressure Cuffs; Manufactured for Vital Signs, Inc., a GE Healthcare Company recall (Z-2581-2011)GE Healthcare, LLC2011-06-22
BrightSpeed Excel Select, BrightSpeed Edge Select ,BrightSpeed Elite Select and BrightSpee recall (Z-2214-2011)GE Healthcare, LLC2011-05-19
Precision 500D X-ray systems with under-table collimator part number 5234960. The Precisio recall (Z-1971-2011)GE Healthcare, LLC2011-05-06
GE The CARESCAPE Monitor B850 includes both new and existing subsystems interconnected to recall (Z-1929-2011)GE Healthcare, LLC2011-04-08
GE Healthcare, CARESCAPE Monitor B650 The CARESCAPE Monitor B650 is a multi-parameter pati recall (Z-1930-2011)GE Healthcare, LLC2011-04-08
GE Healthcare, CARESCAPE Monitor B850 The CARESCAPE Monitor B650 is a multi-parameter pati recall (Z-1931-2011)GE Healthcare, LLC2011-04-08
GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM (SENO ESSENTIAL) The Senographe Esse recall (Z-1041-2011)GE Healthcare, LLC2011-03-18
GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM ( SENO ESSENTIAL) The expected usage recall (Z-1043-2011)GE Healthcare, LLC2011-03-17
GE SENOGRAPHE DS FULL FIELD MAMMOGRAPHY SYSTEM MAMMOGRAPHIC FILM / SCREEN SYSTEM recall (Z-1044-2011)GE Healthcare, LLC2011-03-17
GE Healthcare, ApexPro Telemetry System The ApexPro Telemetry System is intended for use u recall (Z-1522-2011)GE Healthcare, LLC2011-03-03
GE ADVANTAGE SIM MD versions 5.x, 6.x, 7.x up to and including version 7.7.0 Advantage Sim recall (Z-1473-2011)GE Healthcare, LLC2011-03-02
BrightSpeed Excel/Edge/Elite Select Computed Tomography X-Ray System. For head, whole body recall (Z-0286-2011)GE Healthcare, LLC2011-03-01
1) Signa Lx ( K962061 Signa Horizon Cx) The Signa Horizon Cx System is indicated for use a recall (Z-1424-2011)GE Healthcare, LLC2011-02-24
2) Signa Advantage SP (K942604 Signa Advantage SP MR System) A magnetic resonance diagnost recall (Z-1425-2011)GE Healthcare, LLC2011-02-24
3) Signa Advantage (K911959 Signa Advantage MR System) A magnetic resonance diagnostic dev recall (Z-1426-2011)GE Healthcare, LLC2011-02-24
4) Signa HDe (K052978 GE 1.5T Signa HDe MR System) The GE Signa HDe MR system is a whole b recall (Z-1427-2011)GE Healthcare, LLC2011-02-24
5) Signa HDx (K052293 Signa HDx and HDxt MR Systems) Signa HDx or Signa HDxt (K052293 Sign recall (Z-1428-2011)GE Healthcare, LLC2011-02-24
6) Signa Excite (K041476 Signa Excite 1.5T and 3.0T) Signa Excite, 12x (K041476 Signa Exci recall (Z-1429-2011)GE Healthcare, LLC2011-02-24
7) Signa OpenSpeed (K032795 GE 0.7T Signa OpenSpeed with EXCITE MR System) The 0.7T Signa recall (Z-1430-2011)GE Healthcare, LLC2011-02-24
8) Signa 3.0T Infinity with EXCITE (K030874 GE 3.0T Signa Infinity TwinSpeed with EXCITE M recall (Z-1431-2011)GE Healthcare, LLC2011-02-24
9) Signa Excite 1.5 T (Excite II) (K013636 Signa Infinity MR System with EXCITE Technology recall (Z-1432-2011)GE Healthcare, LLC2011-02-24
10) Brivo MR355/Optima MR360 Not yet 510(K) cleared and are not distributed in the US. (K1 recall (Z-1433-2011)GE Healthcare, LLC2011-02-24
GE Healthcare Discovery MR750 3.0T The GE Signa MR750 System is a whole body magnetic reso recall (Z-1375-2011)GE Healthcare, LLC2011-02-18
GE Healthcare Discovery MR450 1.5T, The Discovery MR450 is a whole body magnetic resonance recall (Z-1376-2011)GE Healthcare, LLC2011-02-18
GE Healthcare, Optima MR450w 1.5T MR systems The GE Signa MR750 System is a whole body mag recall (Z-1377-2011)GE Healthcare, LLC2011-02-18
Xeleris Processing and Review Workstation 1.0, 1.1, 2.0, 3.0 The display, processing, arch recall (Z-1250-2011)GE Healthcare, LLC2011-02-15
LightSpeed 16 Computed Tomography X-ray Systems; LightSpeed 16 Computed Tomography X-ray S recall (Z-0942-2011)GE Healthcare, LLC2011-02-07
GE Discovery ST (16 Slice) System; Discovery ST (16 Slice) Systems with technical Referenc recall (Z-0943-2011)GE Healthcare, LLC2011-02-07
GE Healthcare STe (16 slice) System; Discovery STe (16 Slice) Systems with technical Refer recall (Z-0944-2011)GE Healthcare, LLC2011-02-07
GE Healthcare Discovery RX (16 slice) PET/CT System; Discovery RX (16 Slice) PET/CT System recall (Z-0945-2011)GE Healthcare, LLC2011-02-07
GE Healthcare Discovery LS (16 slice) System; Discovery LS (16 Slice) Systems with technic recall (Z-0946-2011)GE Healthcare, LLC2011-02-07
HiSpeed LXI (2200997) recall (Z-0744-2011)GE Healthcare, LLC2011-01-04
HiSpeed LX/l (2200997-2) recall (Z-0745-2011)GE Healthcare, LLC2011-01-04
HiSpeed DX/I (2201000) recall (Z-0746-2011)GE Healthcare, LLC2011-01-04
HiSpeed DX/I (2201000-2) recall (Z-0747-2011)GE Healthcare, LLC2011-01-04
HiSpeed DX/I (2249696) recall (Z-0768-2011)GE Healthcare, LLC2011-01-04
Hi Speed DX/I (2249696-2) recall (Z-0770-2011)GE Healthcare, LLC2011-01-04
HiSpeed FX/I (2200997 with Gantry mo. #2200997) recall (Z-0771-2011)GE Healthcare, LLC2011-01-04
HiSpeed FX/I (2200997 with Gantry mo. #2201000) recall (Z-0772-2011)GE Healthcare, LLC2011-01-04
HiSpeed FX/I (2200997 with Gantry mo. #2200997-2) recall (Z-0773-2011)GE Healthcare, LLC2011-01-04
HiSpeed FX/I (2200997 with Gantry mo. #2201000-2) recall (Z-0774-2011)GE Healthcare, LLC2011-01-04
HiSpeed FX/I (2200997 with Gantry mo. #2249696) recall (Z-0775-2011)GE Healthcare, LLC2011-01-04
HiSpeed FX/I (2200997 with Gantry mo. #2249696-2) recall (Z-0776-2011)GE Healthcare, LLC2011-01-04
HiSpeed FX/I (2200997-2 with Gantry mo. #2200997) recall (Z-0777-2011)GE Healthcare, LLC2011-01-04
HiSpeed FX/I (2200997-2 with Gantry mo. #2200997-2) recall (Z-0778-2011)GE Healthcare, LLC2011-01-04
HiSpeed FX/I (2200997-2 with Gantry mo. #2201000) recall (Z-0779-2011)GE Healthcare, LLC2011-01-04
HiSpeed FX/I (2200997-2 with Gantry mo. #2201000-2) recall (Z-0780-2011)GE Healthcare, LLC2011-01-04
HiSpeed FX/I (2200997-2 with Gantry mo. #2249696) recall (Z-0781-2011)GE Healthcare, LLC2011-01-04
HiSpeed FX/I (2200997-2 with Gantry mo. #2249696-2) recall (Z-0782-2011)GE Healthcare, LLC2011-01-04
HiSpeed FX/I (2201000-2 with Gantry mo. #2200997) recall (Z-0783-2011)GE Healthcare, LLC2011-01-04
HiSpeed FX/I (2201000-2 with Gantry mo. #2200997-2) recall (Z-0784-2011)GE Healthcare, LLC2011-01-04
HiSpeed FX/I (2201000-2 with Gantry mo. #2201000) recall (Z-0785-2011)GE Healthcare, LLC2011-01-04
HiSpeed FX/I (2201000-2 with Gantry mo. #2201000-2) recall (Z-0786-2011)GE Healthcare, LLC2011-01-04
HiSpeed FX/I (2201000-2 with Gantry mo. #2249696) recall (Z-0787-2011)GE Healthcare, LLC2011-01-04
HiSpeed FX/I (2201000-2 with Gantry mo. #2249696-2) recall (Z-0788-2011)GE Healthcare, LLC2011-01-04
XELERIS (1.0, 1.1, 2.0 & 2.1) PROCESSING AND REVIEW WORKSTATION The display, processing, a recall (Z-0537-2011)GE Healthcare, LLC2010-12-03
GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 recall (Z-0476-2011)GE Healthcare, LLC2010-11-26
GE Healthcare IDI Mammo Workstation recall (Z-0477-2011)GE Healthcare, LLC2010-11-26
Signa Excite" 1.5 T Magnetic Resonance Systems, manufactured by GE Healthcare, P.O. Box 44 recall (Z-0462-2011)GE Healthcare, LLC2010-11-24
Signa OpenSpeed, 0.7T MR Systems (HFO3-5). recall (Z-0425-2011)GE Healthcare, LLC2010-11-19
Signa Ovation, 0.35T MR Systems (MFO 1-4). Indicated for use as a diagnostic imaging devic recall (Z-0426-2011)GE Healthcare, LLC2010-11-19
Innova 2121-IQ/3131--1Q Biplane Cardiovascular Imaging System. The Innova Biplane systems recall (Z-0407-2011)GE Healthcare, LLC2010-11-17
Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane position recall (Z-0408-2011)GE Healthcare, LLC2010-11-17
Innova 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, recall (Z-0409-2011)GE Healthcare, LLC2010-11-17
Innova 4100/4100IQ GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The sys recall (Z-0410-2011)GE Healthcare, LLC2010-11-17
Innova 4100/4100IQ GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The sys recall (Z-0392-2011)GE Healthcare, LLC2010-11-16
Innova 2000 The principle system components include a C-arm, image acquisition, processing recall (Z-0393-2011)GE Healthcare, LLC2010-11-16
Power supply boards on Dash 3000, 4000 and 5000 Monitors. GE Healthcare, 8200 West Tower A recall (Z-0359-2011)GE Healthcare, LLC2010-11-15
GE Healthcare Transport Pro Monitor with the CARESCAPE" Patient Data Module. recall (Z-0363-2011)GE Healthcare, LLC2010-11-15
GE LightSpeed VCT Scanner System, models 5212920-300, 5212920-310, 5311595-10. Composed of recall (Z-0368-2011)GE Healthcare, LLC2010-11-15
GE BrightSpeed Excel/Edge/Elite Select / Elite CT Scanner System, models 2377708-560, 5377 recall (Z-0369-2011)GE Healthcare, LLC2010-11-15
GE Datex-Ohmeda Aisys Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN- recall (Z-0008-2011)GE Healthcare, LLC2010-10-06
GE Datex-Ohmeda Avance Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN recall (Z-0009-2011)GE Healthcare, LLC2010-10-06
GE Datex-Ohmeda Amingo Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN recall (Z-0010-2011)GE Healthcare, LLC2010-10-06
CARESCAPE MONITOR B850 Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acui recall (Z-2275-2010)GE Healthcare, LLC2010-08-25
Innova 2000, manufactured by GE Medical Systems, SCS recall (Z-2238-2010)GE Healthcare, LLC2010-08-19
DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 ( Datek-Ohmeda Network and iCent recall (Z-2211-2010)Ge Healthcare, Llc2010-08-12
Innova 2100IQ system with InnovaIQ Table Option Indicated for use in generating fluoroscop recall (Z-1921-2010)Ge Healthcare, Llc2010-06-29
Innova 3100/ 3100IQ system with InnovaIQ Table Option Indicated for use in generating fluo recall (Z-1922-2010)Ge Healthcare, Llc2010-06-29
Innova 4100/4100IQ system with InnovaIQ Table Option Indicated for use in generating fluor recall (Z-1923-2010)Ge Healthcare, Llc2010-06-29
DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 recall (Z-1814-2010)Ge Healthcare, Llc2010-06-22
GE Healthcare, CARESCAPE" Monitor B850, Software version 1.0.1.13 and 1.0.2.1 The CARESCAP recall (Z-1801-2010)Ge Healthcare, Llc2010-06-11
GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 Seno recall (Z-1747-2010)Ge Healthcare, Llc2010-06-02
GE Healthcare, Innova 4100 IQ: GE Innova 4100 / 4100 IQ., Cardiovascular Imaging System (T recall (Z-1659-2010)Ge Healthcare, Llc2010-05-26
GE Healthcare, Innova 3100 IQ : GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, ( recall (Z-1660-2010)Ge Healthcare, Llc2010-05-26
GE Healthcare, Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a mon recall (Z-1661-2010)Ge Healthcare, Llc2010-05-26
GE, 1011-9000-000 Aisys Anesthesia Machine and Monitor recall (Z-1526-2010)Ge Healthcare, Llc2010-05-11
GE, 1009-9002-000 Avance Anesthesia Machine and Monitor recall (Z-1527-2010)Ge Healthcare, Llc2010-05-11
Definium 5000 X-ray System, model number 5220493 and 5220393-2 recall (Z-1118-2009)GE Healthcare, LLC2009-09-25
GE Healthcare MUSE Cardiology Information Systems vs. 7.0, 7.0.1, 7.0.2, 7.1, 7.1.1. The M recall (Z-1719-2009)GE Healthcare, LLC2009-08-14
← Previous

Track GE Healthcare LLC automatically

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