PlainRecalls

GE Healthcare

63 recalls on record · Latest: Apr 9, 2025

FDA Devices Moderate Apr 9, 2025

GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; 2) 2066908-086; 3) 2066908-136; 4) 2104867…

FDA Devices Moderate Apr 9, 2025

GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 2033901-001; 3) 2038437-001; 4) 2038437-011; 5) 203843…

FDA Devices Moderate Apr 9, 2025

GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; 3) 2049587-011; 4) 2049587-012; 5) 2049587-015;…

FDA Devices Moderate Apr 9, 2025

GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-009; 4) 2038437-014; 5) 203…

FDA Devices Moderate Nov 13, 2024

GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2089507-083, GDZH-JINWAN-Centricity 2) 2089507-093, 10510-3-Centricit…

FDA Devices Moderate Oct 16, 2024

GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a)¿¿¿¿¿ 2089507-120; b)¿¿¿¿ 2089507-129; c)¿¿¿¿¿ …

FDA Devices Moderate Oct 2, 2024

GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.

FDA Devices Moderate Nov 1, 2023

Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System

FDA Devices Moderate Nov 1, 2023

Universal Viewer Workflow Manager, Image processing radiological system

FDA Devices Moderate Nov 1, 2023

Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System

FDA Devices Moderate Sep 9, 2020

The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures.…

FDA Devices Moderate Jun 13, 2018

Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images…

FDA Devices Moderate Apr 11, 2018

GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW by GE Healthcare is a device…

FDA Devices Moderate Nov 18, 2015

GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w …

FDA Devices Moderate Nov 18, 2015

GE Healthcare, SIGNA Excite 3.0T. MR System for use as a diagnostic imaging device.

FDA Devices Moderate Nov 18, 2015

GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner fo…

FDA Devices Moderate Nov 18, 2015

GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open, whole body scanner for use as a diagnostic imaging device…

FDA Devices Moderate Nov 18, 2015

GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a whole body magnetic resonance scanner for use as a diagnostic imaging d…

FDA Devices Moderate Nov 11, 2015

The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and data from various imaging sources. Images…

FDA Devices Moderate Nov 11, 2015

The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. I…

FDA Devices Moderate Oct 14, 2015

Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various i…

FDA Devices Moderate Sep 30, 2015

Lightspeed 16 CT

FDA Devices Moderate Sep 30, 2015

PET Discovery LS

FDA Devices Moderate Sep 30, 2015

PET Discovery ST 16

FDA Devices Moderate Sep 2, 2015

Centricity Universal Viewer Product Usage: The Centricity Universal Viewer Version 6.0 software is a picture archiving and communications system,…

FDA Devices Moderate Sep 2, 2015

Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Universal Viewer is a picture archiving and communications sy…

FDA Devices Moderate Jul 29, 2015

GE Healthcare Precision 500D Classical R & F system.

FDA Devices Moderate Jul 29, 2015

GE Healthcare Precision RXi 23A/32A Analog System

FDA Devices Moderate Jul 8, 2015

GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems. A universal diagnostic imaging system for radiogra…

FDA Devices Moderate Jul 8, 2015

GE Healthcare Optima IGS 320. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, in…

FDA Devices Moderate Jul 8, 2015

GE Healthcare Discovery IGS 730. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic,…

FDA Devices Moderate Jul 8, 2015

GE Healthcare Optima CL 323i. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, in…

FDA Devices Moderate Jul 8, 2015

GE Healthcare Innova 2121IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, int…

FDA Devices Moderate Jul 8, 2015

GE Healthcare Innova IGS 520. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, in…

FDA Devices Moderate Jul 8, 2015

GE Healthcare Innova 2100IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, int…

FDA Devices Moderate Jul 8, 2015

GE Healthcare Innova IGS 530. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, in…

FDA Devices Moderate Jul 8, 2015

GE Healthcare Innova IGS 630. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, in…

FDA Devices Moderate Jul 8, 2015

GE Healthcare Innova IGS 620. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, in…

FDA Devices Moderate Jul 8, 2015

GE Healthcare Discovery IGS 740 & GE Healthcare Innova IGS 740. Angiographic X-ray systems used in generating fluoroscopic and rotational images o…

FDA Devices Moderate Jul 1, 2015

GE Healthcare, Treadmill T2100. For Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within speed range of 0…

FDA Devices Moderate Jun 3, 2015

D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors. Pr…

FDA Devices Moderate May 27, 2015

CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designed to be a head and whole body CT scanner utilizing a new solid state det…

FDA Devices Moderate May 20, 2015

GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).

FDA Devices Moderate May 13, 2015

GE Discovery MR950 MRI system

FDA Devices Moderate May 6, 2015

GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx

FDA Devices Moderate May 6, 2015

GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx

FDA Devices Moderate May 6, 2015

GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx

FDA Devices Moderate Apr 22, 2015

Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems.

FDA Devices Moderate Apr 1, 2015

GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCI…

FDA Devices Moderate Mar 25, 2015

GE Healthcare, Treadmill T2100 and Treadmill T2000 with power cord part numbers 408930-001 Rev E, 408930-002 Rev C, or 2028038-008 Rev B. Also Field …