Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

763 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. Astraia software GmbH, 2022-02-02 CAPA AST-7150,astraia - software for women's health - obstretic and gynaecological database application

    We would like to inform you as the user/reseller of astraia about a possible bug in transferring measurement data, used for the ...

    Waarschuwing | 29-09-2022

  2. ShenZhen Cleanmo Technology, IT2045270, flocked swabs for nasal samples collection

    The AR received the signal that the exported swabs are missing the four-digit number of the Notified Body.Through investigation, ...

    Waarschuwing | 28-09-2022

  3. Sentec AG, CAPA 0599, NeoContactAgent Kit

    Met dit Marktveiligheidsbericht willen wij u informeren dat zichtbare verontreiniging werd ontdekt in ongeveer 0.1% van de ...

    Waarschuwing | 27-09-2022

  4. FARAPULSE, 92912936-FA, FARAWAVE - FARASTAR - FARAPULSE SYSTEM

    Het FARAPULSE PFA-systeem is ontworpen/beoogd voor gebruik voor de isolatie van longaderen tijdens de ablatie van paroxismaal ...

    Waarschuwing | 26-09-2022

  5. Löwenstein Medical SE & Co. KG, FSCA2022013, elisa 600, elisa 800 und elisa 800 vit

    De NIST-connectoren vormen de verbinding tussen de gasslangen en de ventilator. Elke NIST-connector is voor een specifiek gastype ...

    Waarschuwing | 22-09-2022

  6. Thermo Fisher Scientific, FSN-2022-009, SAB GLUC AGAR +GENTAM+CHLORAMPH

    A technical investigation has concluded that there is no inhibition of one target organism ( Pseudomonas aeruginosa) on this Lot

    Waarschuwing | 16-09-2022

  7. CareDx AB, A-2022-114, QTYPE 11

    A known 8*50:01:01:02 sample was typed as 8*50:02 due to an incorrect reactivity in the mix in H7 FAM. 8*50:01:01:02, ...

    Waarschuwing | 16-09-2022

  8. Technomed Europe, NCR 22-063, Disposable Subdermal Needle Electrode, Pt.Ir

    There are still products in the market that are accompanied with a version of the Instructions for use that does not have the MRI ...

    Waarschuwing | 12-09-2022

  9. FUJIFILM medwork, CAPA-2022-031, CrossSnare

    As long as the limit values are exceeded the products might pose a small potential threat to the health of users or patients ...

    Waarschuwing | 07-09-2022

  10. AAT Alber Antriebstechnik GmbH, FSN-07-22, V-MAX² P1605 Schiebe- und Bremshilfe

    From May 2021 to July 2022, motor brake units were installed in individual V-MAX² push and brake aids, some of which were not ...

    Waarschuwing | 05-09-2022