Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.589 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Arthrex INC, R537_NL, Knee Scorpion™
Associated outer labels and label content document for indicated batches display a sterility statement indicating “sterile” via ...
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Philips Medical Systems Nederland BV, 2023-IGT-BST-013, Philips Allura Xper, Azurion and MultiDiagnost -E
Philips has become aware of a potential safety issue with the wired and wireless foot switch used with the Philips Allura Xper, ...
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BioMérieux SA, FSCA #5763-1, BK VIRUS R-GENE
The aim of this communication is to inform you about low positive signals (aspecific signals below Ct corresponding to the limit ...
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Ethicon LLC, 2283226 (2) - PDS Clear Suture Breakage Complaints, PDS II Suture
lnternal testing on returned product from this lot confirmed that some POS™ Il (polydioxanone) Sutures from this lot did not meet ...
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Siemens Healthcare Diagnostics Inc., CHC 23-01, ADVIA Chemistry Urinary.Cerebrospinal Fluid Protein
Falsely depressed ECRE_2 results may be observed when the assay is processed after the UCFP test on ADVIA Chemistry systems.
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Draeger Medical Systems Inc., PR132825, Babyroo TN300
During the course of our global market surveillance activities, we have become aware that the TN300 Babyroo Radiant Warmer ...
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Medion Grifols Diagnostics AG, 800012088, Screen-Cyte 0.8%
During our routine vigilance process, it has been detected that a small subset of kits (13 kits in total} of the three-cell ...
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Olympus Medical Systems Corporation, Disposale EMR Kit
Since Olympus has confirmed that alternative products can be provided, Olympus has decided to ask our customers to cease using ...
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Hamilton Medical AG, HAMILTON-C1 HAMILTON-T1 HAMILTON-C2 HAMILTON-C3
We have become aware of a malfunction with our HAMILTON-C2/C3/C1/T1 ventilators when used long term in neonatal patient group.
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Dragerwerk AG en Co. KGaA, PR132399, HME TwinStar Plus and corresponding sets
The current Filter/HME TwinStar® Plus Instructions for Use contain warnings related to condensate. However, we determined that ...