34 results
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11ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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SCNHD LA L7-4 HDI Transducer Probe
FDA Recall
Open, Classified
·Philips Ultrasound, Inc·Product code ITX·July 3, 2025
ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code JIS·April 15, 2025
GE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR System, GE 3.0T SIGNA HDx MR System, GE 1.5T SIGNA HDxt MR System, GE 3.0T SIGNA HDxt MR System, 1.5T SIGNA HDxt, 3.0T SIGNA HDxt, 1.5T SIGNA HDxt Mobile, 3.0T SIGNA HDxt Mobile, SIGNA HDi, SIGNA Vibrant systems, nuclear magnetic resonance imaging systems.
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code LNH·December 23, 2021
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTERINE CURETTE #3 STER25, Model Number 96-4113; 2) ECONO STERILE KEVORK ENDO CURET W/BAS STER25, Model Number 96-4144A; 3) ECONO STERILE KEVORKIAN CURET W/O BAS STER25, Model Number 96-4145A; cervical biopsy
FDA Recall
Open, Classified
·Sklar Instruments·Product code HCY·December 3, 2024
D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action.
FDA Recall
Open, Classified
·Peter Lazic Gmbh Immelmannweg 2 Tuttlingen Germany·Product code HCI·October 6, 2023
D-Clip Standard/Mini Applier, 190mm bayonet, jaw rigid, double action.
FDA Recall
Open, Classified
·Peter Lazic Gmbh Immelmannweg 2 Tuttlingen Germany·Product code HCI·October 6, 2023
D-Clip Standard/Mini Applier, 210mm bayonet, jaw rigid, double action.
FDA Recall
Open, Classified
·Peter Lazic Gmbh Immelmannweg 2 Tuttlingen Germany·Product code HCI·October 6, 2023
GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR, 1.5T SIGNA Creator, 1.5T SIGNA Explorer, 1.5T SIGNA MR355, 1.5T SIGNA MR360, 1.49T SIGNA MR380, SIGNA Voyager, SIGNA Voyager Premier Edition, SIGNA Artist, Optima MR450w 1.5T, Optima MR450w GEM, Discovery MR450 1.5T, GE 1.5T and 3.0T SIGNA HDx, GE 1.5T and 3.0T SIGNA HDxt, 1.5T and 3.0T SIGNA HDxt Mobile, SIGNA HDi, SIGNA Vibrant, SIGNA 1.5T TwinSpeed, SIGNA Infinity Excite, SIGNA Infinity with Excite Technology, SIGNA OpenSpeed, SIGNA HFO, SIGNA HFO/I MR System, GE 0.7T SIGNA OpenSpeed, SIGNA OpenSpeed with Excite, SIGNA HDe, Brivo MR355, Optima MR360, SIGNA 3.0T MR System, SIGNA Excite 3T, 1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD, SIGNA Contour, SIGNA Horizon Cx, SIGNA Horizon Lx, SIGNA Infinity, SIGNA MR/I, SmartSpeed, EchoSpeed Plus, HighSpeed Plus, MR Vectra, MR MAX, Optima MR430s, Optima MR430s 1.5T, Optima MR430s MRI Scanner, 1.0T MSK Extreme, SIGNA Profile EXCITE, SIGNA Ovation, 0.35T SIGNA Ovation with Excite, SIGNA Prime.
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code LNH·March 4, 2022
F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
FDA Recall
Open, Classified
·GE Medical Systems China Co., Ltd. National Hi-Tech No.·Product code MHX·September 8, 2023
GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200
FDA Recall
Open, Classified
·GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.·Product code BSZ·March 21, 2025
GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000
FDA Recall
Open, Classified
·GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.·Product code BSZ·March 21, 2025
GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000
FDA Recall
Open, Classified
·GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.·Product code BSZ·March 21, 2025
GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200
FDA Recall
Open, Classified
·GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.·Product code BSZ·March 21, 2025
GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012
FDA Recall
Open, Classified
·GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.·Product code BSZ·March 21, 2025
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; Carestation 620 A1 REF 1012-9620-000; Carestation 620 A1, REF 1012-9620-200; Carestation 620 A1, REF 1012-9620-202; Carestation 620 SE A1, REF 1012-9620-212; Carestation 630 A1, REF 1012-9650-222; Carestation 650 A1, REF 1012-9650-000; Carestation 650 A1, REF 1012-9650-200; Carestation 650 A1, REF 1012-9650-202; Carestation 650 SE A1, REF 1012-9650-212; Carestation 650c A1, REF 1012-9655-202; Anesthesia Gas Machine Products for which affected PMB can be used as a spare part: Carestation 620 A2, REF 1012-9620-002 00840682124546 Carestation 620 SE A2, REF 1012-9620-012 00195278569677 Carestation 650 A2, REF 1012-9650-002 00840682124560 Carestation 650 SE A2, REF 1012-9650-012 00195278569684 Carestation 650c A1, REF 1012-9655-000 00840682103954 Carestation 650c A2, REF 1012-9655-002 00840682124539 Carestation 650c A1, REF 1012-9655-200 00195278439543
FDA Recall
Open, Classified
·GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.·Product code BSZ·November 14, 2025
GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002
FDA Recall
Open, Classified
·GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.·Product code BSZ·March 21, 2025
GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000
FDA Recall
Open, Classified
·GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.·Product code BSZ·March 21, 2025
GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002
FDA Recall
Open, Classified
·GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.·Product code BSZ·March 21, 2025
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, REF 1012-9750-000; Carestation 750 A2, REF 1012-9750-002; Carestation 750c A1, REF 1012-9755-000; Products for which affected PMB can be used as a spare part: Carestation 750c A2, REF 1012-9755-002
FDA Recall
Open, Classified
·GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.·Product code BSZ·November 14, 2025
GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200
FDA Recall
Open, Classified
·GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No.·Product code BSZ·March 21, 2025