Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.324 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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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 ...
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Philips Medical Systems Nederland B.V., 2023-PD-CTAMI-010, Spectral CT 7500
Philips has identified multiple software issues affecting Spectral CT 7500 systems. The detailed descriptions of these issues are ...
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Philips Medical Systems, FSCA 2023-CC-HPM-046, CareEvent
It has been discovered that background notifications for the Care Assist application fail to send from PIC iX Event Notification ...
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GeneProof a.s., FSCA 00623(b), GeneProof Enterovirus PCR Kit
Op basis van feedback van klanten hebben we de potentiële aspecificiteiten van de GeneProof Enterovirus PCR Kit onderzocht met ...
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Becton, Dickinson and Company, IDS-23-4910, BD BACTEC™ MicroMGIT Calibration Vial
Becton, Dickinson and Company has confirmed through 45 (forty-five) customer complaints that the BD BACTEC™ MicroMGIT™ ...
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DiaSys Deutschland Vertriebs-GmbH, NCR 24-12, GLDH FS DGKC
Using the a.m. lots of GLDH FS DGKC cause falsely high results when measured in quality controls or patient samples
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Ameco Medical Industries, VIG-33-2023-FC03, AMECATH Short Term Haemodialysis Catheter
Luxation of the catheter due to suture-wing detaching from catheter with lot number 21006
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Stihler Electronic GmbH, #2023-11 (FSN), #2024-01 (FSCA), ASTOPAD
SOF and COV applied parts manufactured from May 2022 to October 2023 may potentially have internal (not visible from outside) ...
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ARDO medical AG, FSCA 2023-01, Master
Some devices (Master) can overheat due to an incorrectly assembled circuit board and as a result therefore switches off. This ...
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Cardiac Pacemaker Inc, 92977025-FA, Model 3120 ZOOM PRM with Model 2892 Software
Vanaf 10 januari 2024 geeft de klokparameter die wordt gebruikt door de softwaretoepassing van Model 2892 in de Model 3120 ...