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Medical devicesSafety Notices

After placing a medical device on the market, a manufacturer is required to track and if necessary to improve it. The manufacturer must take action if a risk exists for the user. The manufacturer must inform users and the Inspectorate of such action by a Field Safety Notice. This might include a recall, amended instructions for use or extra information about the medical device.

Field Safety Notices about medical devices that have been reported to the Inspectorate on the Dutch market are shown below. The Inspectorate began publishing these notices online on 15 December 2015.

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  1. Field Safety Notice: OLYMPUS, MONOPOLAR HF RESECTION ELECTRODES 23-05-2017

    OLYMPUS has initiated this FSCA after receiving an increased number of complaints regarding loop wires breaking at the distal end of the referenced electrodes.

  2. Field Safety Notice: Mölnlycke, Barrier Sets03-05-2017

    During an investigation of a product complaint, microholes has been detected after immersion test on some of Barrier Sets.

  3. Field Safety Notice: Beckman Coulter, UniCel DxH 800 en 600 Coulter Cellular Analysis System03-05-2017

    There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a...

  4. Field Safety Notice: LivaNova Deutschland GmbH, Heater Cooler 3T 03-05-2017

    LivaNova is issuing an updated Field Safety Notice to inform users about the retrofit of their Heater Cooler 3T devices.

  5. Field Safety Notice: Abbott Diagnostics, ARCHITECT Free T428-04-2017

    This Product Correction letter is being issued to provide you with information regarding a change of measuring interval for the ARCHITECT Free T4 assay list numbers...

  6. Field Safety Notice: Hitachi, OUTPUT UNIT27-04-2017

    One complaint was received referring to 5 position racks at the Output Unit were not being smoothly pushed out into the tray, possibly leading to spilling of the sample...

  7. Field Safety Notice: Siemens Healthcare, ADVIA Centaur Systems Insulin Assay26-04-2017

    Siemens Healthcare Diagnostics is providing this Urgent Field Safety Notice to communicate the restoration of the ADVIA Centaur Systems Insulin (IRI) assay to World...

  8. Field Safety Notice: Randox Laboratories, Liquid Cardiac Control25-04-2017

    Randox has confirmed a change in recovery with regards to CKMB in lot 3912CK of the Liquid Cardiac Control.

  9. Field Safety Notice: CareFusion - Alaris GS, GH, CC, TIVA, PK, Enteral Syringe Pump25-04-2017

    Naar aanleiding van meldingen van één klant eind 2016 heeft BD/CareFusion een potentieel risico met betrekking tot de sifonwerking van de spuit geconstateerd bij Alaris...

  10. Field Safety Notice: Cook Medical - Pereyra-Raz Ligature Carrier etc24-04-2017

    We have identified the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.