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All Recalls

Every Ge Healthcare, Llc Recall

Sorted by most recent. Click any recall for full details.

309 recalls
High RiskFDA
Ge Healthcare, Llc
Discovery Ml DR Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (...
Medical Devices·1,113 affected·Feb 12, 2019
High RiskFDA
Ge Healthcare, Llc
Discovery Ml Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET...
Medical Devices·1,113 affected·Feb 12, 2019
High RiskFDA
Ge Healthcare, Llc
Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography app...
Cardiac Devices·857 affected·Jan 19, 2019
High RiskFDA
Ge Healthcare, Llc
GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model BT09 (b) Model BT07 Product Usage: The device is intended f...
Cardiac Devices·1,897 affected·Dec 28, 2018
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Centricity Universal Viewer Breast Imaging Centricity Universal Viewer is a device that displays medical images and d...
Diagnostic Devices·297 affected·Dec 20, 2018
High RiskFDA
Ge Healthcare, Llc
System, Tomography Computed Emmission
Medical Devices·526 affected·Nov 30, 2018
High RiskFDA
Ge Healthcare, Llc
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, S...
Medical Devices·508 affected·Nov 9, 2018
CriticalFDA
Ge Healthcare, Llc
GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box of ten singles) ...
Respiratory Devices·1,140 affected·Oct 5, 2018
High RiskFDA
Ge Healthcare, Llc
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 UPGRAD...
Medical Devices·4,207 affected·Sep 27, 2018
High RiskFDA
Ge Healthcare, Llc
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 UP...
Respiratory Devices·4,207 affected·Sep 27, 2018
High RiskFDA
Ge Healthcare, Llc
Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 11.X ENGLISH FOR USA, TOUCHSCREEN DISPLAY KIT ...
Respiratory Devices·4,207 affected·Sep 27, 2018
High RiskFDA
Ge Healthcare, Llc
Giraffe Incubator Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1
Medical Devices·1,724 affected·Sep 25, 2018
High RiskFDA
Ge Healthcare, Llc
Panda Freestanding Warmer. Device sold under the following product names: Panda Freestanding Warmer and Panda Freestanding Warmer Generi...
Medical Devices·1,724 affected·Sep 25, 2018
High RiskFDA
Ge Healthcare, Llc
Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1
Medical Devices·1,724 affected·Sep 25, 2018
High RiskFDA
Ge Healthcare, Llc
Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radiant warmer.
Medical Devices·1,724 affected·Sep 25, 2018
CriticalFDA
Ge Healthcare, Llc
GE Healthcare Millennium MC
Medical Devices·18 affected·Sep 14, 2018
CriticalFDA
Ge Healthcare, Llc
GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System
Medical Devices·1,166 affected·Sep 14, 2018
CriticalFDA
Ge Healthcare, Llc
GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System
Medical Devices·276 affected·Sep 14, 2018
CriticalFDA
Ge Healthcare, Llc
GE LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended for use by a qualified physician for ultrasound evaluation of...
Cardiac Devices·103 affected·Sep 14, 2018
High RiskFDA
Ge Healthcare, Llc
PROCARE B20 Patient Monitor, V1; and B20 Patient Monitor, V2. The PROCARE Monitor B20 is a portable multiparameter unit to be used for...
Medical Devices·28,004 affected·Sep 11, 2018
High RiskFDA
Ge Healthcare, Llc
B20i Patient Monitor and B20i V2 Patient Monitor. The device is a portable multiparameter unit to be used for monitoring and recording...
Medical Devices·6,458 affected·Sep 11, 2018
High RiskFDA
Ge Healthcare, Llc
B40i Patient Monitor and B40i Patient Monitor V3 The device is a portable multiparameter unit to be used for monitoring and recording ...
Medical Devices·6,864 affected·Sep 11, 2018
High RiskFDA
Ge Healthcare, Llc
PROCARE B40 Patient Monitor, V1; and B40 Patient Monitor, V2, V2.1, and V3. The PROCARE Monitor B40 is a portable multiparameter unit ...
Medical Devices·33,065 affected·Sep 11, 2018
High RiskFDA
Ge Healthcare, Llc
Dash 5000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Medical Devices·182,640 affected·Aug 31, 2018
High RiskFDA
Ge Healthcare, Llc
Solar 9500 Information Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Medical Devices·3,864 affected·Aug 31, 2018
High RiskFDA
Ge Healthcare, Llc
Solar 8000M Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Medical Devices·73,673 affected·Aug 31, 2018
High RiskFDA
Ge Healthcare, Llc
Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Medical Devices·182,640 affected·Aug 31, 2018
High RiskFDA
Ge Healthcare, Llc
Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher.
Medical Devices·1 affected·Aug 30, 2018
High RiskFDA
Ge Healthcare, Llc
CT Goldseal Optima CT 600
Medical Devices·42 affected·May 24, 2018
High RiskFDA
Ge Healthcare, Llc
Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG WAUK; d. MID BJG; e. MID WAUK.
Medical Devices·42 affected·May 24, 2018
High RiskFDA
Ge Healthcare, Llc
Discovery MI Digital Ready
Medical Devices·42 affected·May 24, 2018
High RiskFDA
Ge Healthcare, Llc
Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the...
Medical Devices·4 affected·May 24, 2018
High RiskFDA
Ge Healthcare, Llc
Discovery IQ 2.0 20cm, 4 ring, Model Number 5432539-22
Medical Devices·42 affected·May 24, 2018
High RiskFDA
Ge Healthcare, Llc
Optima CT 520
Medical Devices·42 affected·May 24, 2018
High RiskFDA
Ge Healthcare, Llc
Optima CT 540
Medical Devices·42 affected·May 24, 2018
High RiskFDA
Ge Healthcare, Llc
Revolution CT 160 1.5D STD WAUK
Medical Devices·42 affected·May 24, 2018
High RiskFDA
Ge Healthcare, Llc
Discovery NM/CT 670 Pro, model 5376204-70-54
Medical Devices·1 affected·May 24, 2018
High RiskFDA
Ge Healthcare, Llc
Uterine Electromyographic Monitor -Monica IF24 Interface System Product Usage: The Monica IF24 CTG Interface Device is an accessory t...
Medical Devices·355 affected·Dec 15, 2017
High RiskFDA
Ge Healthcare, Llc
Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Product Usage: The Novii Interface is an accessory to the Novi...
Medical Devices·1,742 affected·Dec 15, 2017
High RiskFDA
Ge Healthcare, Llc
Discover VH/Millennium VG Nuclear Medicine Imaging System
Medical Devices·339 affected·Oct 30, 2017
High RiskFDA
Ge Healthcare, Llc
DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.
Medical Devices·2 affected·Oct 4, 2017
High RiskFDA
Ge Healthcare, Llc
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of specific inhalation anesthetic agents for use in cont...
Medical Devices·28 affected·Oct 4, 2017
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Optima CT520 X-ray system
Medical Devices·10,884 affected·May 19, 2017
High RiskFDA
Ge Healthcare, Llc
GE Healthcare lnnova IGS 540 ACT X-ray system
Medical Devices·10,884 affected·May 19, 2017
High RiskFDA
Ge Healthcare, Llc
GE Healthcare BrightSpeed X-ray system
Medical Devices·10,884 affected·May 19, 2017
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Discovery NM/CT 570c X-ray system
Medical Devices·10,884 affected·May 19, 2017
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Discovery NM/CT 670. 670 Pro, 670 ES X-ray system
Medical Devices·10,884 affected·May 19, 2017
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Discovery Ml DR X-ray system
Medical Devices·10,884 affected·May 19, 2017