Browse recalls
Country of alert: China
- 2026-08-11 · US FDA — Medical DevicesClass II
Computed Tomography X-ray System, Model: uCT 530 with software - 2026-08-11 · US FDA — Medical DevicesClass II
Computed Tomography X-ray System, Model: uCT 550 with software - 2026-08-11 · US FDA — Medical DevicesClass II
Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software - 2026-08-11 · US FDA — Medical DevicesClass II
Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with software - 2026-08-11 · US FDA — Medical DevicesClass II
Computed Tomography X-ray System, Model: uCT 780 with software - 2026-08-11 · US FDA — Medical DevicesClass II
Computed Tomography X-ray System, Model: uCT ATLAS with software - 2026-08-11 · US FDA — Medical DevicesClass II
Computed Tomography X-ray System, Model: uCT ATLAS Astound with software - 2026-08-11 · US FDA — Medical DevicesClass II
Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo with software - 2026-08-11 · US FDA — Medical DevicesClass II
Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS with software - 2026-08-11 · US FDA — Medical DevicesClass II
Computed Tomography X-ray System, Model: uCT 760 with software - 2026-08-11 · US FDA — Medical DevicesClass II
Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software - 2026-08-11 · US FDA — Medical DevicesClass II
Positron Emission Tomography and Computed Tomography System, Model: uMI 780 - 2025-11-22 · US FDA — Medical DevicesClass II
Male Fertility Sperm Test for Home Use (Cassette) - 2025-11-22 · US FDA — Medical DevicesClass II
Exploro Highly Sensitive Male Fertility / Sperm Concentration Test - 2025-11-22 · US FDA — Medical DevicesClass II
Vivoo Protein Test - 2025-11-22 · US FDA — Medical DevicesClass II
LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in - 2025-11-22 · US FDA — Medical DevicesClass II
S. Typhi/Para Typhi A Antigen - 2025-11-14 · US FDA — Medical DevicesClass I
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; - 2025-05-16 · US FDA — Medical DevicesClass II
GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system - 2025-04-25 · US FDA — Medical DevicesClass III
AcoSound. Model Number: LW12-BTE-M - 2025-03-21 · US FDA — Medical DevicesClass I
GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002 - 2025-03-21 · US FDA — Medical DevicesClass I
GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000 - 2025-03-21 · US FDA — Medical DevicesClass I
GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002 - 2025-03-21 · US FDA — Medical DevicesClass I
GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012 - 2025-03-21 · US FDA — Medical DevicesClass I
GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200 - 2025-03-21 · US FDA — Medical DevicesClass I
GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002 - 2025-03-21 · US FDA — Medical DevicesClass I
GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002 - 2025-03-21 · US FDA — Medical DevicesClass I
GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012 - 2025-03-21 · US FDA — Medical DevicesClass I
GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002 - 2025-03-21 · US FDA — Medical DevicesClass I
GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000 - 2025-01-31 · US FDA — Medical DevicesClass II
Brivo MR355, NMRI system - 2025-01-31 · US FDA — Medical DevicesClass II
SIGNA Creator, SIGNA Explorer, NMRI systems - 2025-01-31 · US FDA — Medical DevicesClass II
SIGNA MR355, SIGNA MR360, NMRI system - 2025-01-10 · US FDA — Medical DevicesClass II
DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software. - 2024-11-05 · US FDA — Medical DevicesClass II
GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems - 2024-11-05 · US FDA — Medical DevicesClass II
GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system - 2024-11-05 · US FDA — Medical DevicesClass II
GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomography system - 2024-11-05 · US FDA — Medical DevicesClass II
GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as: - 2024-11-05 · US FDA — Medical DevicesClass II
GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/computed tomography system - 2024-11-05 · US FDA — Medical DevicesClass II
GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems - 2024-11-05 · US FDA — Medical DevicesClass II
GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/computed tomography system - 2024-11-05 · US FDA — Medical DevicesClass II
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA: EU: Operator Console (for BrightSpeed, - 2024-11-05 · US FDA — Medical DevicesClass II
GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system - 2024-11-05 · US FDA — Medical DevicesClass II
GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography system - 2024-11-05 · US FDA — Medical DevicesClass II
GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomography system - 2024-11-05 · US FDA — Medical DevicesClass II
GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system - 2024-11-05 · US FDA — Medical DevicesClass II
GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systems - 2024-11-05 · US FDA — Medical DevicesClass II
GE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000-2, 3) 6670000-200, 4) 6670000-6; X-r - 2024-11-05 · US FDA — Medical DevicesClass II
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA: China Only: Discovery CT750HD - 2024-07-12 · US FDA — Medical DevicesClass II
GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999;