| SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance I recall (Z-2476-2024) | GE Medical Systems, LLC | 2024-08-02 |
| Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magn recall (Z-2477-2024) | GE Medical Systems, LLC | 2024-08-02 |
| Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Mag recall (Z-2478-2024) | GE Medical Systems, LLC | 2024-08-02 |
| SIGNA Prime, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging S recall (Z-2479-2024) | GE Medical Systems, LLC | 2024-08-02 |
| SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging recall (Z-2480-2024) | GE Medical Systems, LLC | 2024-08-02 |
| SIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic Resonance Ima recall (Z-2481-2024) | GE Medical Systems, LLC | 2024-08-02 |
| Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic Resonance Imagi recall (Z-2482-2024) | GE Medical Systems, LLC | 2024-08-02 |
| SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance Im recall (Z-2483-2024) | GE Medical Systems, LLC | 2024-08-02 |
| SIGNA MAGNUS, with affected software versions: MR29.1, RX29.1; Nuclear Magnetic Resonance recall (Z-2484-2024) | GE Medical Systems, LLC | 2024-08-02 |
| Vivid S5 Ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdomina recall (Z-0752-2023) | GE Medical Systems, LLC | 2022-12-22 |
| Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdomina recall (Z-0753-2023) | GE Medical Systems, LLC | 2022-12-22 |
| Vivid S5 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in recall (Z-0754-2023) | GE Medical Systems, LLC | 2022-12-22 |
| Vivid S6 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in recall (Z-0755-2023) | GE Medical Systems, LLC | 2022-12-22 |
| Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374 recall (Z-0756-2023) | GE Medical Systems, LLC | 2022-12-22 |
| Vivid q ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal recall (Z-0757-2023) | GE Medical Systems, LLC | 2022-12-22 |
| Vivid i N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in F recall (Z-0758-2023) | GE Medical Systems, LLC | 2022-12-22 |
| Vivid q N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in F recall (Z-0759-2023) | GE Medical Systems, LLC | 2022-12-22 |
| B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX, recall (Z-0729-2023) | GE Medical Systems, LLC | 2022-12-19 |
| B125P Patient Monitor (with E-module slot option), REF 6160000-002 recall (Z-0730-2023) | GE Medical Systems, LLC | 2022-12-19 |
| B105M Patient Monitor, REF 6160000-003 recall (Z-0731-2023) | GE Medical Systems, LLC | 2022-12-19 |
| B125M Patient Monitor, REF 6160000-004-XXXXXX recall (Z-0732-2023) | GE Medical Systems, LLC | 2022-12-19 |
| B125M Patient Monitor, REF 6160000-005-XXXXXXX recall (Z-0733-2023) | GE Medical Systems, LLC | 2022-12-19 |
| Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Incl recall (Z-0721-2023) | GE Medical Systems, LLC | 2022-12-16 |
| Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and recall (Z-0722-2023) | GE Medical Systems, LLC | 2022-12-16 |
| Brivo MR355, Optima MR360 Product Usage: The Brivo MR355/Optima MR360 is a whole body magn recall (Z-3021-2017) | GE Medical Systems, LLC | 2017-08-02 |
| Optima MR450 1.5T Product Usage: 1 .5T Brivo MR355 and 1.5T Optima MR360 are whole body ma recall (Z-3022-2017) | GE Medical Systems, LLC | 2017-08-02 |
| Optima MR750 3.0T Product Usage: The Optima MR450 1.5T system is a whole body magnetic res recall (Z-3023-2017) | GE Medical Systems, LLC | 2017-08-02 |
| Optima MR450w 1.5T Product Usage: The Optima MR450w 1.5T system is a whole body magnetic r recall (Z-3024-2017) | GE Medical Systems, LLC | 2017-08-02 |
| Discovery MR750 3.0T Product Usage: Intended use: The Discovery MR750 3.0Tsystem is a whol recall (Z-3025-2017) | GE Medical Systems, LLC | 2017-08-02 |
| SIGNA Creator, SIGNA ExplorerProduct Usage: 1.5T SIGNA Creator and 1.5T SIGNA Explorer is recall (Z-3026-2017) | GE Medical Systems, LLC | 2017-08-02 |
| 1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant recall (Z-3027-2017) | GE Medical Systems, LLC | 2017-08-02 |
| 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The 1.5T Signa H recall (Z-3028-2017) | GE Medical Systems, LLC | 2017-08-02 |
| Signa PET/MR (K163619, K142098) Product Usage: The SIGNA PET/MR system combines magnetic r recall (Z-3029-2017) | GE Medical Systems, LLC | 2017-08-02 |
| GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscopic and rotatio recall (Z-1706-2016) | GE Medical Systems, LLC | 2016-05-23 |
| GE Healthcare, Discovery IGS 740. Indicated for use in generating fluoroscopic and rotatio recall (Z-1707-2016) | GE Medical Systems, LLC | 2016-05-23 |
| GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular X-ra recall (Z-1589-2016) | GE Medical Systems, LLC | 2016-04-29 |
| GE Healthcare, Optima XR220amx, Mobile Digital Ready Radiographic System Designed to gener recall (Z-0768-2016) | GE Medical Systems, LLC | 2016-02-08 |
| GE Healthcare, Brivo XR285amx Mobile Digital Ready Radiographic System Designed to generat recall (Z-0769-2016) | GE Medical Systems, LLC | 2016-02-08 |
| GE Healthcare, Optima XR200amx, Mobile Digital Ready Radiographic System Designed to gener recall (Z-0770-2016) | GE Medical Systems, LLC | 2016-02-08 |
| GE Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000. The family of GE recall (Z-0677-2016) | GE Medical Systems, LLC | 2016-01-21 |
| GE Healthcare, Aestiva 7900, 1006-9305-000. This version of the Datex-Ohmeda 7900 ventilat recall (Z-0678-2016) | GE Medical Systems, LLC | 2016-01-21 |
| GE Healthcare, Aestiva MRI, 1006-9310-000. This version of the Datex-Ohmeda 7900 ventilato recall (Z-0679-2016) | GE Medical Systems, LLC | 2016-01-21 |
| GE Healthcare, Aisys, 1011-9000-000. The GE Datex-Ohmeda Aisys Anesthesia System is intend recall (Z-0680-2016) | GE Medical Systems, LLC | 2016-01-21 |
| GE Healthcare, Aisys CS2,1011-9050-000; Avance Amingo,1009-9002-000, & Avance CS2, 1009-90 recall (Z-0681-2016) | GE Medical Systems, LLC | 2016-01-21 |
| Anesthesia device service kits. ASSY-MSN, VENT ENGINE ASSY, 1503-8101-000 ASSY-MSN, VENT E recall (Z-0682-2016) | GE Medical Systems, LLC | 2016-01-21 |
| GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2. recall (Z-0201-2019) | GE Medical Systems, LLC | 2015-12-28 |
| GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050SS. Product Usage The 3.0T GE 6 recall (Z-0553-2016) | GE Medical Systems, LLC | 2015-12-28 |
| MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UPDATE 11-4-2015: recall (Z-0196-2016) | GE Medical Systems, LLC | 2015-10-30 |
| HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 224780 recall (Z-0007-2011) | GE Medical Systems, LLC | 2010-12-17 |
| Infinia with Hawkeye 1, model numbers: H2508PW, H2508PY, H3000WN, H3000WR, H3000WW, H3000W recall (Z-0494-2010) | GE Medical Systems, LLC | 2010-01-21 |
| Infinia with Hawkeye 4, model numbers: H3000WC and H3000WD. GE Healthcare, Waukesha, Wisco recall (Z-0495-2010) | GE Medical Systems, LLC | 2010-01-21 |
| Millenium VG with Hawkeye/Discovery VH with Hawkeye, model number: BR321000008. GE Healthc recall (Z-0496-2010) | GE Medical Systems, LLC | 2010-01-21 |
| GE Healthcare MAC 800 RESTING ECG ANALYSIS SYSTEM. The MAC 800 is a portable EGG acquisiti recall (Z-0645-2010) | GE Medical Systems, LLC | 2010-01-21 |
| Omega IV and Omega V tables on GE Advantx-E imaging system, used for general purpose diagn recall (Z-0616-2010) | GE Medical Systems, LLC | 2010-01-13 |
| Omega IV and Omega V tables on GE Innova 2100IQ Digital Fluoroscopic Imaging System recall (Z-0617-2010) | GE Medical Systems, LLC | 2010-01-13 |
| Omega IV and Omega V tables on GE Innova 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascu recall (Z-0618-2010) | GE Medical Systems, LLC | 2010-01-13 |
| Omega IV and Omega V tables on GE Innova 4100/4100IQ GE Innova 4100 / 4100 IQ., x-ray syst recall (Z-0619-2010) | GE Medical Systems, LLC | 2010-01-13 |
| Omega IV and Omega V tables on GE Innova 2000 fluoroscopic x-ray system recall (Z-0620-2010) | GE Medical Systems, LLC | 2010-01-13 |
| Omega IV and Omega V tables on GE Innova 2121-1Q/3131--1Q Biplane Cardiovascular Imaging S recall (Z-0621-2010) | GE Medical Systems, LLC | 2010-01-13 |
| Signa Excite 1.5T, Signa HD 1.5T, Signa HDx 1.5T, Signa HDxT 1.5T, Signa HDe, GE DISCOVERY recall (Z-0592-2010) | GE Medical Systems, LLC | 2010-01-11 |
| GE Healthcare Proteus XR/a. Model # 2259988. GE Healthcare, 3000 North Grandview, Waukesha recall (Z-0526-2010) | GE Medical Systems, LLC | 2009-12-16 |
| GE Healthcare Revolution XR/d. Model #'s 2259988-2 & 2351505. GE Healthcare, 3000 North Gr recall (Z-0527-2010) | GE Medical Systems, LLC | 2009-12-16 |
| GE Healthcare Definium 8000.Model # 5131070. GE Healthcare, 3000 North Grandview, Waukesha recall (Z-0528-2010) | GE Medical Systems, LLC | 2009-12-16 |
| GE Healthcare, Innova 2121-1Q/3131-1Q Biplane Cardiovascular Imaging Systems. Indicated fo recall (Z-0540-2010) | GE Medical Systems, LLC | 2009-12-16 |
| GE Healthcare Voluson E6, GE Voluson E8, and GE Voluson E8 Expert Diagnostic Ultrasound Sy recall (Z-0541-2010) | GE Medical Systems, LLC | 2009-12-16 |
| GE Medical Systems, COMPAX 40E X-ray Systems, Models; 2208203, 2208205, 2244282, 2244284, recall (Z-0457-2010) | GE Medical Systems, LLC | 2009-11-25 |
| GE Healthcare, GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, (The system consis recall (Z-0135-2010) | GE Medical Systems, LLC | 2009-11-09 |
| GE Healthcare, GE Innova 2100 IQ Versatile Cardiac and Vascular Imaging System, (The syste recall (Z-0136-2010) | GE Medical Systems, LLC | 2009-11-09 |
| GE Healthcare, GE Innova 4100 / 4100 IQ. , ( The system consists of an a monoplane positio recall (Z-0137-2010) | GE Medical Systems, LLC | 2009-11-09 |
| Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System. recall (Z-0138-2010) | GE Medical Systems, LLC | 2009-11-09 |
| GE Healthcare CT Systems Table Model Number 2225283 used on LightSpeed 1X through 4X and H recall (Z-1257-2009) | GE Medical Systems, LLC | 2009-09-25 |
| GE Healthcare CT Systems Table Model Number 2271242 used on LightSpeed 1X through 4X and H recall (Z-1258-2009) | GE Medical Systems, LLC | 2009-09-25 |
| GE Healthcare CT Systems Table Model Number 2269165 used on LightSpeed 1X through 4X and H recall (Z-1259-2009) | GE Medical Systems, LLC | 2009-09-25 |
| Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434 recall (Z-0002-2009) | GE Medical Systems, LLC | 2009-09-24 |
| GE Innova 4100/4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a recall (Z-1036-2009) | GE Medical Systems, LLC | 2009-09-24 |
| GE, Innova 2000 The principle system components include a C-arm, image acquisition, proces recall (Z-2240-2009) | GE Medical Systems, LLC | 2009-09-24 |
| Innova 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, recall (Z-2241-2009) | GE Medical Systems, LLC | 2009-09-24 |
| Innova 4100/4100IQ GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 (The syst recall (Z-2242-2009) | GE Medical Systems, LLC | 2009-09-24 |
| Revolution XR/d systems with control room PC model 5117866-2 with Software collector 51943 recall (Z-0003-2009) | GE Medical Systems, LLC | 2009-09-22 |
| GE Healthcare CT/e and HiSpeed X/i, families of computed tomography Systems with Gantry. T recall (Z-2224-2009) | GE Medical Systems, LLC | 2009-09-18 |
| Sytec 6000, Sytec 8000, and Lemage/ProSeed/ProSpeed families. The CT/e and HiSpeed X/i fam recall (Z-2225-2009) | GE Medical Systems, LLC | 2009-09-18 |
| GE Healthcare Ventri, GE Healthcare, Waukesha, WI. Model number(s): H3000YW, H3000YY, H300 recall (Z-2219-2009) | GE Medical Systems, LLC | 2009-09-17 |
| GE Healthcare, Uni-Circuit Kit, Adult, Disposable, 1.8 m/72 in, REF M1089028, M1087972, M1 recall (Z-1870-2009) | GE Medical Systems, LLC | 2009-09-09 |
| Datex-Ohmeda S/5 Device Interfacing Solution, N-DISVENT 02. The Datex-Ohmeda S/5 Device In recall (Z-1558-2009) | GE Medical Systems, LLC | 2009-09-04 |
| GE Medical Systems, OEC, Vascular Drape, 00-902776-01, Sterile. 150" long x 87" wide. Dist recall (Z-1706-2009) | GE Medical Systems, LLC | 2009-09-01 |
| Sterile, Drape, Headset, Lower, Part Number 888944-01. recall (Z-1707-2009) | GE Medical Systems, LLC | 2009-09-01 |
| Sterile, Drape, Headset, Upper, Part Number 888945-01. recall (Z-1708-2009) | GE Medical Systems, LLC | 2009-09-01 |
| Disposable Pack, Headset Part Number 888946-01(kit includes Part Number 888944-01, Sterile recall (Z-1709-2009) | GE Medical Systems, LLC | 2009-09-01 |
| GE Healthcare Signa Ovation 0.35T, Model Numbers: Ovation 1-3 (2276937), Ovation 4 (237706 recall (Z-1722-2009) | GE Medical Systems, LLC | 2009-08-25 |
| Signa Openspeed 0.7T MR Systems, Model Numbers: Openspeed 3 (2138300-30), Openspeed 4 (237 recall (Z-1723-2009) | GE Medical Systems, LLC | 2009-08-25 |
| AdvantageSim MD versions 7.4 through 7.6, Model 5160092. AdvantageSim MD is used to prepar recall (Z-1718-2009) | GE Medical Systems, LLC | 2009-08-17 |
| GE Healthcare, Drapes and Sterile Covers PART NUMBER DESCRIPTION 00-900352-01 DRAIN BAG W/ recall (Z-1730-2009) | GE Medical Systems, LLC | 2009-08-14 |
| GE Healthcare, CT Perfusion 4 on Advantage Workstation, CT and PET/CT consoles. Image anal recall (Z-1720-2009) | GE Medical Systems, LLC | 2009-08-13 |
| GE Signa Ovation 0.35 T MR System. The Signa Ovation System is an open, whole body scanner recall (Z-1556-2009) | GE Medical Systems, LLC | 2009-06-30 |
| GE Signa OpenSpeed 0.7T MR System. The 0.7T Signa OpenSpeed with Excite Magnetic Resonance recall (Z-1557-2009) | GE Medical Systems, LLC | 2009-06-30 |
| GE Innova 2100 IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha, recall (Z-1474-2009) | GE Medical Systems, LLC | 2009-06-19 |
| GE Innova 3100 / 3100 IQ Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188. recall (Z-1475-2009) | GE Medical Systems, LLC | 2009-06-19 |
| GE Innova 4100 / 4100 IQ Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188. recall (Z-1476-2009) | GE Medical Systems, LLC | 2009-06-19 |
| Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System. The Innova Biplane systems a recall (Z-1195-2009) | GE Medical Systems, LLC | 2009-05-19 |
| GE Healthcare Infinia, Model Numbers: ASM000886, ASM001391, ASM001333, ASM001465, ASM00147 recall (Z-1001-2009) | GE Medical Systems, LLC | 2009-04-21 |