Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.594 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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GE Healthcare Europe GmbH, FSN-FMI 60978, SIGNA PET/MR - 58250 - PET/MR all others - 37654 - MRI system, full-body, superconducting magnet
Incorrect Image Annotation and/or Flipped Images as a result of Inadvertently Changing the Prescribed Patient Orientation. SIGNA ...
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Angiomed_BD PI-21-4115 - Ecoflex Baskets, High Flex Baskets and Gastrotop Bile Endoprosthesis Sets
The impacted Ecoflex Baskets, High Flex Baskets and Gastrotop Bile Endoprosthesis Sets are being removed as BD has become aware, ...
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Varex lmaging Group Nederland B.V., FSN-CAR 3343-FSCA, Optica 30
With this letter Varex lmaging Group Nederland B.V. would like to inform you about a possible safety issue with product Optica 30.
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Katalyst Surgical, LLC, FSN-25062021-2, Bipolar Forceps
This letter is to notify you that, in the interest of pending regulatory matters within the European Union medical device market, ...
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Medsphere International (Shanghai) Co., Ltd., FSN-FB-2021-018, Medsphere Electrodes
Dringende VEILIGHEIDSMEDEDELING Apparaat: MedSphere radiofrequentiesystemen – elektrode.
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Fysicon B.V., CAPA21012, DataLinQ
Fysicon heeft een probleem aangetroffen in de longevity trend grafiek, welke tot een verkeerde interpretatie kan leiden bij ...
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GE Medical Systems Information Technologies, Inc., FSN-FMI 36149, Patient Data Module
URGENTE VEILIGHEIDSMEDEDELING: CARESCAPE PDM Masimo SpO2-saturatiewaarden kunnen bevriezen na langdurig gebruik zonder ...
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Arthrex INC, FSN-R527_NL, Suture Anchor, BioComposite SwiveLock®
Deze veiligheidsmededeling is bedoeld om u te informeren over een terugroeping van het Arthrex hechtdraadanker BioComposite ...
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bioMérieux SA, FSN-FSCA 5230, ETEST®IMIPENEM RELEBACTAM-WW & US
This letter is intended for all ETEST® Imipenem/Relebactam (IPR) (Ref: 420925 & 420927) users.
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MY01 Inc., FSCA-2021-001, MY01 Continuous Compartmental Pressure Monitor
For the affected product Lots listed in Appendix 1, MY01 Inc. has identified that there is a potentially nonconforming version of ...