Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.325 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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NOxBOX Ltd, VIG-23-03, NOxBOXi
NBL has worked with the third-party supplier of the manifold to investigate this issue and has determined that the malfunction is ...
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Elekta Ltd, FCA-ESAB-0004, Elekta Unity
Er is een kleine kans dat een elektrische connector in de MR-gradiëntspoel oververhit raakt bij gebruik van Elekta Unity-systemen.
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NRT X-Ray A.S, FSCA_PR20230201-01, Intelli-C
This FSN is distributed to inform users about a risk that a driveshaft in the IDE movement may break, which may lead to ...
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Cook Endoscopy.Wilson Cook Medical Inc., 2023FA0006, Hemospray Endoscopic Hemostat
Adhesion of the powder to the endoscope or endoscope to the tissue can result in delay in treatment, mucosal tear, perforation, ...
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Draeger Medical Systems Inc., PR129416, Softbed Resuscitaire with Scale
During the course of our global market surveillance activities, we have become aware of cases in which the Resuscitaire Infant ...
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SCILO Vertriebs GmbH, 004.2023, Inzision-Instrument 70 mm
SCILO has currently received a complaint from a user about soiling or discolouration on the round, transparent incision template.
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Armstrong Medical Ltd, SI22-170, AQUAVENT NEO neonatal CPAP limb heated
A report has been made to Armstrong Medical of tubing (and a connector attached to the tubing) disconnecting from the elbow ...
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Siemens Healthcare Diagnostics Inc, ACHC 23-03, Atellica CH Toxicology Calibrator
Siemens Healthcare Diagnostics Inc. received customer complaints regarding a positive bias for the Atellica CH Salicylate (Sal) ...
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Phadia AB, QA2023-05, EliA GBM Well
Several customer complaints have been reported where specific samples produced false positive EliA GBM results. An investigation ...
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Roche Diagnostics GmbH, SBN-RDS-CoreLab-2023-003, aPTT, aPTT Lupus, aPTT Screen
During internal measurements, carryover from PT Rec and PT Rec-based factor assays (FII, FV, FVII, FX) to aPTT assays (aPTT, aPTT ...