GE Healthcare, LLC: 234 recalls on record

Recalls filed with 1 agency: FDA (234).

First recall on record: June 27, 2012. Most recent: April 8, 2026.

Risk classification: Class I: 24 · Class II: 208 · Class III: 2

Most recent recalls

DateAgencyProduct
February 12, 2014FDAGE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The…Z-0911-2014
February 5, 2014FDAGE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARESCAPE Monitor…Z-0854-2014
February 5, 2014FDAGE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Intended to produ…Z-0840-2014
February 5, 2014FDAGE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imaging System. …Z-0853-2014
January 29, 2014FDAVideo Monitor Suspensions that may be on the following Fluoroscopic and Radiographic X-Ra…Z-0804-2014
January 29, 2014FDAGE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Modul…Z-0808-2014
January 29, 2014FDAGE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the…Z-0806-2014
January 29, 2014FDASOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAP…Z-0807-2014
January 22, 2014FDAGE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. …Z-0725-2014
January 22, 2014FDAGE Healthcare Carescape Patient Data Module The Patient Data Module (PDM) is intended…Z-0747-2014
January 15, 2014FDASOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAP…Z-0648-2014
December 25, 2013FDAMulti Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, packag…Z-0472-2014
December 18, 2013FDAHGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor…Z-0489-2014
November 27, 2013FDAGE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615. T…Z-0367-2014
November 27, 2013FDAGE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, wh…Z-0373-2014
November 20, 2013FDAAW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH A…Z-0270-2014
October 23, 2013FDAGE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for vol…Z-0010-2014
October 23, 2013FDAGE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 41…Z-0021-2014
October 23, 2013FDAGE, Optima CT660. Intended to produce cross-sectional images of the body by computer r…Z-0023-2014
October 23, 2013FDAGE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure …Z-0009-2014
October 23, 2013FDAGE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation …Z-0024-2014
October 23, 2013FDAGE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is intended for use…Z-0012-2014
October 9, 2013FDAGE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5T . sc…Z-2291-2013
October 2, 2013FDAGE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model…Z-2266-2013
September 25, 2013FDAGE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 51836…Z-2257-2013

Questions about this company

How many recalls does GE Healthcare, LLC have?
Recalert has 234 U.S. recalls on record for GE Healthcare, LLC, published between June 27, 2012 and April 8, 2026.
Which agencies have handled GE Healthcare, LLC recalls?
GE Healthcare, LLC appears as the recalling firm in recalls from: FDA (234).

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