GE Healthcare, LLC
324 recalls on record · Latest: Aug 31, 2022
FDA Devices Moderate Apr 24, 2019
Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vas…
FDA Devices Low Apr 3, 2019
Integrated ECG cable with 3-lead leadwires labeled as the following: 1. ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, AHA, 3.6 M/12 FT…
FDA Devices Moderate Feb 13, 2019
GE Healthcare Centricity Universal Viewer Breast Imaging Centricity Universal Viewer is a device that displays medical images and data from var…
FDA Devices Moderate Feb 6, 2019
GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model BT09 (b) Model BT07 Product Usage: The device is intended for use by a …
FDA Devices Moderate Jan 16, 2019
Discover VH/Millennium VG Nuclear Medicine Imaging System
FDA Devices Moderate Dec 26, 2018
Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.…
FDA Devices Moderate Dec 19, 2018
PROCARE B20 Patient Monitor, V1; and B20 Patient Monitor, V2. The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring …
FDA Devices Moderate Dec 19, 2018
Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the evaluation …
FDA Devices Moderate Dec 19, 2018
B20i Patient Monitor and B20i V2 Patient Monitor. The device is a portable multiparameter unit to be used for monitoring and recording of, and to …
FDA Devices Moderate Dec 19, 2018
B40i Patient Monitor and B40i Patient Monitor V3 The device is a portable multiparameter unit to be used for monitoring and recording of, and to g…
FDA Devices Moderate Dec 19, 2018
GE LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obste…
FDA Devices Moderate Dec 19, 2018
PROCARE B40 Patient Monitor, V1; and B40 Patient Monitor, V2, V2.1, and V3. The PROCARE Monitor B40 is a portable multiparameter unit to be used f…
FDA Devices Moderate Dec 19, 2018
Discovery NM/CT 670 Pro, model 5376204-70-54
FDA Devices Critical Dec 12, 2018
GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box of ten singles) The CARES…
FDA Devices Moderate Dec 5, 2018
Dash 5000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
FDA Devices Moderate Dec 5, 2018
Solar 9500 Information Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
FDA Devices Moderate Dec 5, 2018
Solar 8000M Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
FDA Devices Moderate Dec 5, 2018
Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
FDA Devices Moderate Nov 28, 2018
Giraffe Incubator Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1
FDA Devices Moderate Nov 28, 2018
Panda Freestanding Warmer. Device sold under the following product names: Panda Freestanding Warmer and Panda Freestanding Warmer Generic ATO Model.…
FDA Devices Moderate Nov 28, 2018
Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1
FDA Devices Moderate Nov 28, 2018
Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radiant warmer.
FDA Devices Moderate Nov 28, 2018
Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded Warmer.
FDA Devices Moderate Nov 21, 2018
Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLIS…
FDA Devices Moderate Nov 21, 2018
Aisys CS2 Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT EN…
FDA Devices Critical Nov 21, 2018
GE Healthcare Millennium MC
FDA Devices Critical Nov 21, 2018
GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System
FDA Devices Moderate Nov 21, 2018
Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 11.X ENGLISH FOR USA, TOUCHSCREEN DISPLAY KIT 11.X ENGLISH…
FDA Devices Critical Nov 21, 2018
GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System
FDA Devices Moderate Oct 24, 2018
Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher.
FDA Devices Moderate Aug 8, 2018
CT Goldseal Optima CT 600
FDA Devices Moderate Aug 8, 2018
Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG WAUK; d. MID BJG; e. MID WAUK.
FDA Devices Moderate Aug 8, 2018
Discovery MI Digital Ready
FDA Devices Moderate Aug 8, 2018
Discovery IQ 2.0 20cm, 4 ring, Model Number 5432539-22
FDA Devices Moderate Aug 8, 2018
Optima CT 520
FDA Devices Moderate Aug 8, 2018
Optima CT 540
FDA Devices Moderate Aug 8, 2018
Revolution CT 160 1.5D STD WAUK
FDA Devices Moderate Aug 8, 2018
Discovery MI, labeled as Discovery DMI 15 cm 3 ring, and Discovery DMI 20cm 4 ring
FDA Devices Moderate Aug 8, 2018
Discovery RT labeled as: a. MID BJG; b. HVY BJG
FDA Devices Moderate Aug 1, 2018
Brivo XR385, model 5215463, Digital Diagnostic Radiographic System
FDA Devices Moderate Apr 11, 2018
Uterine Electromyographic Monitor -Monica IF24 Interface System Product Usage: The Monica IF24 CTG Interface Device is an accessory to the Monica…
FDA Devices Moderate Apr 11, 2018
Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Product Usage: The Novii Interface is an accessory to the Novii Pod which …
FDA Devices Moderate Apr 4, 2018
DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.
FDA Devices Moderate Apr 4, 2018
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow …
FDA Devices Moderate Jul 19, 2017
Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
FDA Devices Moderate Jun 21, 2017
GE Healthcare Optima CT520 X-ray system
FDA Devices Moderate Jun 21, 2017
Infant Warmer System (IWS)
FDA Devices Moderate Jun 21, 2017
GE Healthcare lnnova IGS 540 ACT X-ray system
FDA Devices Moderate Jun 21, 2017
GE Healthcare BrightSpeed X-ray system
FDA Devices Moderate Jun 21, 2017