214 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). Model Numbers: PCF-H180AI, PCF-H180AL, PCF-H190DI, PCF-H190DL, PCF-H190I, PCF-H190L, PCF-H190TI, PCF-H190TL, PCF-HQ190I, PCF-HQ190L, PCF-PH190I, PCF-PH190L, PCF-Q180AI, PCF-Q180AL, PCF-S.
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code NWB·September 25, 2023
Colonoscope, Model Number PCF-H190L.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FDF·January 11, 2024
Colonoscope, Model Number PCF-H180AL.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code NWB·January 11, 2024
Colonoscope, Model Number PCF-H190DL.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code NWB·January 11, 2024
Colonoscope, Model Number PCF-Q180AL.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code NWB·January 11, 2024
Colonoscope, Model Number PCF-H190TL.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code NWB·January 11, 2024
Colonoscope, Model Number PCF-HQ190L.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code NWB·January 11, 2024
PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FDF·October 16, 2023
PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FDF·October 16, 2023
Olympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscope
FDA Recall
Terminated
·Integrated Medical Systems Inc·Product code GCQ·January 20, 2016
Olympus, Model No. PCF-Q180AL, flexible scope, large diameter, video colonoscope
FDA Recall
Terminated
·Integrated Medical Systems Inc·Product code GCQ·January 20, 2016
Olympus, Model No. PCF-140L, flexible scope, large diameter, video colonoscope
FDA Recall
Terminated
·Integrated Medical Systems Inc·Product code GCQ·January 20, 2016
Olympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatric colonoscope
FDA Recall
Terminated
·Integrated Medical Systems Inc·Product code GCQ·January 20, 2016
Olympus, Model No. PCF-H190L, flexible scope, large diameter, video pediatric colonoscope
FDA Recall
Terminated
·Integrated Medical Systems Inc·Product code GCQ·January 20, 2016
CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
FDA Recall
Terminated
·Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code JAA·December 19, 2019
IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)
FDA Recall
Terminated
·AGFA Corp.·Product code LLZ·July 27, 2012
Olympus PCF-Q180AC Video Colonoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code NWB·December 17, 2018
Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum and sigmoid colon). Model Number: PCF-S.
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code NWB·September 25, 2023
The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks. For use in a hospital environment. eCareManager allows clinicians to generate a PDF display of an order (new, change, discontinue), which is printed at the bedside and/or hospital pharmacy. This printed PDF should be reviewed by the clinician and verified by the hospital pharmacist and entered into the hospital pharmacy system.
FDA Recall
Terminated
·Visicu, Inc.·Product code MSX·March 27, 2015
Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.
FDA Recall
Open, Classified
·Haag-Streit USA Inc·Product code HJO·April 15, 2021