Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
152 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Olympus Europa SE & Co. KG, FY25-EMEA-09-FY23-OSTA-13-SoltiveWirelessFootswitch, Soltive Laser System
Olympus investigated complaints received where customers reported difficulties in pairing the wireless footswitch with the ...
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Maquet Cardiovascular, LLC/Getinge, 2242352-05/21/2024-001-C, VASOVIEW HEMOPRO, VASOVIEW HEMOPRO 2
lf there is fluid ingress into the handle of the operating tool, the device may not provide cautery or may continue to provide ...
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Olympus Medical Systems Corporation, HD Lightweight Pendulum Camera Head
Olympus idenfied the repair process for 36 HD Camera Heads (CH-S200-08-LB) did not align with the manufacturing process final ...
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Cook Ireland Ltd, 2024FA0002, ECHO-19: EchoTip® Ultra Endoscopic Ultrasound Needle; ECHO-HD-19-A: EchoTip® Ultra HD Ultrasound Access Needle
Tijdens het routinematige endotoxineprogramma zijn niveaus van bacteriële endotoxine geconstateerd die buiten specificatie ...
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Gyrus ACMI, Inc. (Olympus Surgical Technologies America), QIL FY25-EMEA-01-FY23-OSTA-14-InstaClear Sheath, INSTACLEAR SHEATH
Olympus is taking this corrective action after investigating a complaint for an InstaClear Sheath (Model # LCS4K30BTOL) in which ...
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Ace Medical Devices PVT LTD, AFSCA.01.2023-00, Ace Bladder Evacuator
Mogelijke complicaties van blaasbreuken / perforaties / scheuren in verband met het gebruik van dit apparaat zijn aan de ...
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Intuitive Surgical, Inc., ISIFA2024-02-R, SureForm45/60, Cannula Seal, Arm Drape, Obturator
Intuitive is tot de ontdekking gekomen dat er bepaalde partijen verzonden zijn die over hun officiële vervaldatum waren.
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Olympus Medical Systems Corporation, QIL FY24-EMEA-38-FY24-OMSC-06, High Flow Insufflation Unit
Olympus has become aware of an increased trend from both repairs and customer complaints of the “UHI-4 stopping CO2 gas supply ...
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Gyrus ACMI, Inc. (Olympus Surgical Technologies America), QIL FY24-EMEA-36-FY24-OSTA-06, SOLTIVE SuperPulsed Laser System
As part of Olympus’ post market surveillance of Soltive Laser use, including a review of customer complaints and adverse events, ...
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Coloplast A/S, FSCA_20240223_Ureteral dilator, Ureteral Dilator (Ch/Fr 12-14, length 48 cm)
In de faciliteit van Coloplast is bij sommige urethraledilatorproducten een mogelijk steriliteitsprobleem ontdekt. Dit probleem ...