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
January 4, 2017FDAPrestige SIZ-0912-2017
January 4, 2017FDAADVANTX LCV+Z-0908-2017
January 4, 2017FDAADVANTX LCAZ-0905-2017
January 4, 2017FDAInnova 2000Z-0904-2017
January 4, 2017FDALegacyZ-0909-2017
January 4, 2017FDARFXZ-0915-2017
January 4, 2017FDAPrestilixZ-0914-2017
January 4, 2017FDAPrestige VHZ-0913-2017
December 21, 2016FDAGE Healthcare, Avance, Avance CS2, Amingo.Z-0755-2017
July 13, 2016FDAGE Healthcare, Discovery MR750wZ-2131-2016
December 24, 2014FDADiscovery IGS 740 Indicated for use for patients from newborn to geriatric in generati…Z-0452-2015
December 24, 2014FDAInnova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for…Z-0453-2015
December 24, 2014FDAInnova IGS 540 Indicated for use for patients from newborn to geriatric in generating …Z-0451-2015
November 19, 2014FDABrivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Models…Z-0189-2015
November 19, 2014FDADiscovery NM 630, dual detector free-geometry integrated nuclear imaging system. Models …Z-0187-2015
November 19, 2014FDADiscovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Model…Z-0186-2015
November 19, 2014FDAOptima NM/CT 640, Models H3100YA, H3100YC. Product Usage: The GE Optima NM/CT 640 s…Z-0188-2015
November 19, 2014FDAGE Healthcare Varicam/VG and VG Hawkeye devices. Models H3000YA, H3000YB, H3000YC, H300…Z-0185-2015
November 19, 2014FDAGE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye…Z-0184-2015
October 15, 2014FDAGE Healthcare Carescape Patient Data ModuleZ-0060-2015
October 8, 2014FDAGE Healthcare Precision 500D, Classical R&F System. Product Usage: The Precision 500D…Z-0010-2015
September 17, 2014FDACARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the …Z-2617-2014
August 27, 2014FDAGE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiogr…Z-2291-2014
July 30, 2014FDADATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/…Z-2068-2014
July 30, 2014FDAGE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.Z-2085-2014

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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