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GE Healthcare LLC

397 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
SIGNA Premier systems recall (Z-1767-2026)GE Healthcare LLC2026-04-02
(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Vie recall (Z-1566-2022)GE Healthcare, LLC2022-08-24
Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700, GT2000/VT2 recall (Z-1511-2022)GE Healthcare, LLC2022-08-10
GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and A recall (Z-1389-2022)GE Healthcare, LLC2022-07-19
GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display recall (Z-1333-2022)GE Healthcare, LLC2022-07-05
CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update 3/1 recall (Z-1265-2022)GE Healthcare, LLC2022-06-13
Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators ( recall (Z-1226-2022)GE Healthcare, LLC2022-06-06
Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, E recall (Z-1227-2022)GE Healthcare, LLC2022-06-06
Centricity Universal Viewer Zero Footprint Client recall (Z-1229-2022)GE Healthcare, LLC2022-06-03
Centricity Enterprise Web recall (Z-1230-2022)GE Healthcare, LLC2022-06-03
Centricity Radiology RA600 recall (Z-1231-2022)GE Healthcare, LLC2022-06-03
Centricity Cardiology CA1000 recall (Z-1232-2022)GE Healthcare, LLC2022-06-03
Centricity PACS RA1000 recall (Z-1233-2022)GE Healthcare, LLC2022-06-03
GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect recall (Z-0983-2022)GE Healthcare, LLC2022-04-21
Revolution Apex, Revolution CT with Apex Edition recall (Z-0815-2022)GE Healthcare, LLC2022-04-05
Revolution CT, Revolution CT ES recall (Z-0816-2022)GE Healthcare, LLC2022-04-05
Signa 1.5T TwinSpeed Magnetic Resonance Imaging System recall (Z-0857-2022)GE Healthcare, LLC2022-04-04
1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System recall (Z-0858-2022)GE Healthcare, LLC2022-04-04
SIGNA Excite 3T. Magnetic Resonance Imaging System recall (Z-0859-2022)GE Healthcare, LLC2022-04-04
1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Re recall (Z-0860-2022)GE Healthcare, LLC2022-04-04
GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, recall (Z-0808-2022)GE Healthcare, LLC2022-03-16
GE Vscan Extend, being sold as "Vscan Extend Console" recall (Z-0518-2022)GE Healthcare, LLC2022-01-24
GE Vscan Extend, being sold as "Vscan Extend Dual DICOM" recall (Z-0519-2022)GE Healthcare, LLC2022-01-24
GE Vscan Extend, being sold as "Vscan Extend Dual USB" recall (Z-0520-2022)GE Healthcare, LLC2022-01-24
GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi" recall (Z-0521-2022)GE Healthcare, LLC2022-01-24
GE Vscan Extend, being sold as "Vscan Extend Sector DICOM" recall (Z-0522-2022)GE Healthcare, LLC2022-01-24
GE Vscan Extend, being sold as "Vscan Extend Sector USB" recall (Z-0523-2022)GE Healthcare, LLC2022-01-24
GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi" recall (Z-0524-2022)GE Healthcare, LLC2022-01-24
Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution C recall (Z-0242-2022)GE Healthcare, LLC2021-11-24
SIGNA Premier nuclear magnetic resonance imaging system recall (Z-0132-2022)GE Healthcare, LLC2021-10-16
SIGNA Architect nuclear magnetic resonance imaging system recall (Z-0133-2022)GE Healthcare, LLC2021-10-16
SIGNA Pioneer nuclear magnetic resonance imaging system recall (Z-0134-2022)GE Healthcare, LLC2021-10-16
Discovery MR750w 3.0T nuclear magnetic resonance imaging system recall (Z-0135-2022)GE Healthcare, LLC2021-10-16
Discovery MR750 3.0T nuclear magnetic resonance imaging system recall (Z-0136-2022)GE Healthcare, LLC2021-10-16
SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system recall (Z-0137-2022)GE Healthcare, LLC2021-10-16
SIGNA Voyager nuclear magnetic resonance imaging system recall (Z-0138-2022)GE Healthcare, LLC2021-10-16
SIGNA Artist nuclear magnetic resonance imaging system recall (Z-0139-2022)GE Healthcare, LLC2021-10-16
Optima MR450w 1.5T nuclear magnetic resonance imaging system recall (Z-0140-2022)GE Healthcare, LLC2021-10-16
1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system recall (Z-0141-2022)GE Healthcare, LLC2021-10-16
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system recall (Z-0012-2022)GE Healthcare, LLC2021-10-02
AMX Navigate Mobile X-Ray System recall (Z-2590-2021)GE Healthcare, LLC2021-09-29
Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medica recall (Z-2502-2021)GE Healthcare, LLC2021-09-22
Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medi recall (Z-2503-2021)GE Healthcare, LLC2021-09-22
CARESCAPE PDM-Masimo SpO2. Physiological data monitor. recall (Z-2139-2021)GE Healthcare, LLC2021-07-23
SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to supp recall (Z-2052-2021)GE Healthcare, LLC2021-07-12
SIGNA Architect - Product Usage: is a whole body magnetic resonance scanner designed to su recall (Z-2053-2021)GE Healthcare, LLC2021-07-12
SIGNA Pioneer - Product Usage: is a whole body magnetic resonance scanner designed to supp recall (Z-2054-2021)GE Healthcare, LLC2021-07-12
Discovery MR750w 3.0T - Product Usage: is a whole body magnetic resonance scanner designed recall (Z-2055-2021)GE Healthcare, LLC2021-07-12
Discovery MR750 3.0T - Product Usage: is a whole body magnetic resonance scanner designed recall (Z-2056-2021)GE Healthcare, LLC2021-07-12
SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magne recall (Z-2057-2021)GE Healthcare, LLC2021-07-12
SIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance Imaging System recall (Z-2058-2021)GE Healthcare, LLC2021-07-12
SIGNA MR355, SIGNA MR360, Nuclear Magnetic Resonance Imaging System recall (Z-2059-2021)GE Healthcare, LLC2021-07-12
SIGNA MR380, Nuclear Magnetic Resonance Imaging System recall (Z-2060-2021)GE Healthcare, LLC2021-07-12
SIGNA Artist, Nuclear Magnetic Resonance Imaging System recall (Z-2061-2021)GE Healthcare, LLC2021-07-12
SIGNA Voyager, Nuclear Magnetic Resonance Imaging System recall (Z-2062-2021)GE Healthcare, LLC2021-07-12
Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System recall (Z-2063-2021)GE Healthcare, LLC2021-07-12
Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System recall (Z-2064-2021)GE Healthcare, LLC2021-07-12
1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System recall (Z-2065-2021)GE Healthcare, LLC2021-07-12
Revolution CT recall (Z-2004-2021)GE Healthcare, LLC2021-07-08
GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Inno recall (Z-1864-2021)GE Healthcare, LLC2021-06-15
NM/CT 850 Nuclear Medicine / CT Scanners recall (Z-1545-2021)GE Healthcare, LLC2021-05-11
NM/CT 860 Nuclear Medicine / CT Scanners recall (Z-1546-2021)GE Healthcare, LLC2021-05-11
NM/CT 870 DR Nuclear Medicine / CT Scanners recall (Z-1547-2021)GE Healthcare, LLC2021-05-11
MAC VU360, Electrocardiograph recall (Z-0543-2021)GE Healthcare, LLC2020-12-07
CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electro recall (Z-2883-2020)GE Healthcare, LLC2020-08-24
CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter ph recall (Z-2750-2020)GE Healthcare, LLC2020-08-04
CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/ recall (Z-2424-2020)GE Healthcare, LLC2020-06-24
System, Tomography Computed Emmission recall (Z-2258-2020)GE Healthcare, LLC2020-06-03
System, Tomography Computed Emmission recall (Z-2259-2020)GE Healthcare, LLC2020-06-03
Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 008406821 recall (Z-2111-2020)GE Healthcare, LLC2020-05-22
Lunar iDXA bone densitometer recall (Z-1709-2020)GE Healthcare, LLC2020-04-24
Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer recall (Z-1710-2020)GE Healthcare, LLC2020-04-24
Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v17) bone densitometer recall (Z-1711-2020)GE Healthcare, LLC2020-04-24
Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer recall (Z-1712-2020)GE Healthcare, LLC2020-04-24
SIGNA Premier Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body m recall (Z-0874-2020)GE Healthcare, LLC2020-01-28
SIGNA Architect Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body recall (Z-0875-2020)GE Healthcare, LLC2020-01-28
SIGNA Pioneer Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body m recall (Z-0876-2020)GE Healthcare, LLC2020-01-28
SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T Signa HDxt, recall (Z-0877-2020)GE Healthcare, LLC2020-01-28
Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide gene recall (Z-0813-2020)GE Healthcare, LLC2020-01-23
Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended to provide gene recall (Z-0814-2020)GE Healthcare, LLC2020-01-23
Centricity Universal Viewer 6.0, a device that displays medical images and data from vario recall (Z-0819-2020)GE Healthcare, LLC2020-01-17
CARESCAPE Respiratory Module E-sCO recall (Z-0754-2020)GE Healthcare, LLC2020-01-10
CARESCAPE Respiratory Module E-sCOVX recall (Z-0755-2020)GE Healthcare, LLC2020-01-10
CARESCAPE Respiratory Module E-sCAiO recall (Z-0756-2020)GE Healthcare, LLC2020-01-10
CARESCAPE Respiratory Module E-sCAiOV recall (Z-0757-2020)GE Healthcare, LLC2020-01-10
CARESCAPE Respiratory Module E-sCAiOE recall (Z-0758-2020)GE Healthcare, LLC2020-01-10
CARESCAPE Respiratory Module E-sCAiOVE recall (Z-0759-2020)GE Healthcare, LLC2020-01-10
Airway Gas Option N-CAiO recall (Z-0760-2020)GE Healthcare, LLC2020-01-10
Giraffe OmniBed infant warmer recall (Z-0538-2020)GE Healthcare, LLC2019-12-03
Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX; Giraffe OmniBed Carestatio recall (Z-0539-2020)GE Healthcare, LLC2019-12-03
Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmer recall (Z-0540-2020)GE Healthcare, LLC2019-12-03
Giraffe Incubator infant warmer recall (Z-0541-2020)GE Healthcare, LLC2019-12-03
ApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry Sys recall (Z-0175-2020)GE Healthcare, LLC2019-10-23
Proteus XR/a (SlOK : K993090) recall (Z-2449-2019)GE Healthcare, LLC2019-09-20
Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D recall (Z-1964-2019)GE Healthcare, LLC2019-07-12
Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REAL recall (Z-1965-2019)GE Healthcare, LLC2019-07-12
Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled recall (Z-1846-2019)GE Healthcare, LLC2019-07-11
Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled m recall (Z-1847-2019)GE Healthcare, LLC2019-07-11
Centricity Universal Viewer 6.0 Is a device that displays medical images and data from var recall (Z-1910-2019)GE Healthcare, LLC2019-07-01
Centricity PACS Foundation Centricity PACS software product is intended for the storage, r recall (Z-1911-2019)GE Healthcare, LLC2019-07-01
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