Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
152 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
- Datum
- Relevantie
-
Gyrus ACMI, Inc. (Olympus Surgical Technologies America), QIL FY24-EMEA-32-FY24-OSTA-12, SOLTIVE Single-use Laser Fibers
Olympus conducted an internal review of the SOLTIVE Single-use Fibers and identified inconsistencies in the IFU. Olympus is ...
-
Gyrus ACMI, Inc. (Olympus Surgical Technologies America), QIL FY24-EMEA-26-FY24-OSTA-07, EZDilate Fixed Wire (Guided) Balloon
Olympus is taking this recall action after investigating reported complaints about issues inflating, deflating and/or retrieving ...
-
Olympus, QIL FY24-EMEA-19-FY24-OMSC-19, High Flow Insufflation Unit
Olympus has become aware of patients experiencing complications from over insufflation, including arrythmias reported as “short ...
-
Olympus Medical Systems Corporation, QIL FY24-EMEA-13-FY24-OMSC-02-TJF-Q190V-290V-170V, OLYMPUS TJF-Q190V/Q290V/Q170V DUODENOSCOPE
Olympus is initiating this action after becoming aware of recent reports of infections and positive cultures. Olympus is ...
-
Olympus Medical Systems Corporation, QIL FY24-EMEA-21-FY24-OMSC-26 CV-1500, EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500
Olympus has received one complaint that the water delivery tube came in contact with the touch panel and the Air flow button was ...
-
Cook Endoscopy-Wilson Cook Medical, Inc., 2023FA0009, Quantum TTC Biliary Balloon Dilator
Cook Endoscopy/Wilson-Cook Medical, Inc. is initiating a voluntary removal of affected QBD devices from the market because they ...
-
Stryker Endoscopy, RA2023-3234487, Safelight fiber optic cable
Er bestaat kans op ontevredenheid van de gebruiker en letsel bij de patiënt, omdat het probleem kan zorgen voor een klinische ...
-
Cook Endoscopy.Wilson Cook Medical Inc., 2023FA0007, Fusion Lithotripsy Extraction Basket
Er zijn afwijkende Fusion-extractievangnetjes voor lithotripsie vervaardigd en gedistribueerd. Deze afwijking in de vervaardiging ...
-
Olympus Medical Systems Corporation, QIL FY24-EMEA-06-FY24-OMSC-04c, BF-Series Endoscopes
Olympus has received complaints of endobronchial combustion during therapeutic procedures using lasers or argon plasma ...
-
Karl Storz SE Co. KG, 23-0008, FIVE S 5.3x65 sterile for single use
Within the revalidation of the sterilization process the revalidation failed.