Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.589 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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PathoNostics B.V., AsperGenius Resistance Multiplex real-time PCR ki
Negative results do not necessarily indicate absence of an (fungal) infection.
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Gyrus ACMI, Inc., SG PK CUTTING FORCEPS, 5MM, 33CM. Olympus
The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.
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Maquet Cardiopulmonary GmbH, 946521, H 31471#Hemoconcentrator Set BC 140 / H 15981#Set BC 140 Plus
The component "Hemoconcentrator" was assembled into the finished product (Hemoconcentrator tubing set) after its shelf-life had ...
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Gyrus ACMI, Inc., TFL Fiber Cleaver, TFL Fiber Stripper. Olympus
Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fiber stripper or cleaver on a ...
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OriGen Biomedical, Inc., FA-2023-001, Accessory Sets
Deze kennisgeving betreft een terugroepactie/veiligheidsbericht met betrekking tot bepaalde partijen OriGen Biomedical® Accessory ...
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Atrium Medical Corporation, 3011175548-12/13/2023-002-C, Drains Express Single
On November 8, 2023, Getinge received notice from Nurse Assist, LLC that its Sterile Water, USP, 30mL syringes were being ...
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GE Medical Systems SCS, FMI 34134, EVair medical air compressor, Evair 03
GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are ...
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B. Braun Melsungen AG, FSCA-VS-2023-01, Invasive blood pressure transducer set
As users already know, prolonged contact with organic solvents (spray disinfectants) can promote the formation of stress cracks ...
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Siemens Healthcare GmbH, AX010/23/S (FSCA), AX038/23/S (FSN), Sensis
If the Sensis documentation functionality is used it may happen that during adding once-per-study reporting events (Type 1 ...
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Philips Medical Systems Nederland BV, 2023-IGT-BST-020, Philips Azurion 7 M20 FlexArm system with Maquet M
Philips is op de hoogte gebracht van twee mogelijke veiligheidsproblemen met het Azurion 7 M20 Flexarm-systeem ("Flexarm") met ...