Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
1.683 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Vyaire Medical, Inc., FSCA-2025-0003, AirLife™ Infant Heated Wire Circuits
The adapters depicted in Image A, which are included in the accessory bag of the affected product, are used in certain circuit ...
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Philips Medical Systems Nederland B.V., 2025-EI-PCI-001-I, IntelliSpace Cardiovascular
Philips is op de hoogte gesteld van een mogelijk veiligheidsprobleem met IntelliSpace Cardiovascular (ISCV) 6.x, 7.x en 8.x, ...
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LeMaitre Vascular, Inc., CAPA 2025-007, TufTex® Over-the-Wire Embolectomy Catheter, Pruitt® Occlusion Catheter, Pruitt® Irrigation Occlusion Catheter
Inadequate Tray Seals were found on samples from these three product lines.
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Integra LifeSciences Mansfield, 2024-HHE-022B, CODMAN® Disposable Perforator 14mm
During an investigation of complaints, Integra LifeSciences identified that there is an inadequate weld (proud weld) on specific ...
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Philips Medizin Systeme Böblingen GmbH, FSCA-2025-CC-HPM-011, Microstream Advance, VitaLine, FilterLine
Het niet of moeilijk kunnen loskoppelen van de adapter van de endotracheale slang om een procedure zoals het afzuigen of ...
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Siemens Healthcare Diagnostics Inc., AIMC 25-06, Reference Section 8
Erroneously elevated homocysteine may occur as a result of this issue. A positive drift may impact both QC and patient results in ...
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Cook Incorporated, 2025FA0001, Check-Flo Performer® Introducer
Cook Medical identified that devices from the affected device lot may contain the incorrectly sized introducer sheath.
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Cook Incorporated, 2025FA0002, Tornado® Embolization Microcoil™
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.
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Philips Medical Systems Nederland B.V., 2024-PD-CTAMI-005, Brilliance CT Big Bore; Philips CT Big Bore
Philips is zich bewust geworden van twee (2) onbedoelde bewegingsproblemen met betrekking tot de interventionele bediening die ...
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Medtronic, FA1474,Hugo Robotic Assisted Surgery (RAS) System
The Hugo™ RAS system is designed to enable the safe removal of instruments should they become disabled during a procedure. ...