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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: Abbott - Neuromodulatie Implanteerbare pulsgenerator (IPG)12-09-2017

    Er zijn gevallen bekend bij ons bedrijf waarin de Elective Replacement Indicator (ERI) in sommige hulpmiddelen eerder werd geactiveerd dan bedoeld. In deze gevallen...

  2. Field Safety Notice: Philips - Sync Cables & ECG Out Cables11-09-2017

    The Field Safety Notice in March 2016 instructed users on how to avoid the risk when using affected cables, but also informed users that cables would be replaced free...

  3. Field Safety Notice: Medtronic - Medtronic MiniMed Infusiesets11-09-2017

    Medtronic heeft onlangs meldingen gekregen over mogelijke overdosering van insuline, vlak nadat een infusieset vervangen werd, waarbij medisch ingrijpen nodig was.

  4. Field Safety Notice: Merivaara - Knee Chest device07-09-2017

    It came to our knowledge, that during service actions of one device, fixing of stopping sleeve loosened while device was held up. As a cause for this, foot section...

  5. Field Safety Notice: iMDsoft_MDSS - MetaVision® Suite07-09-2017

    Software malfunctions with the MetaVision ICU system resulted in an unnoticed Order Management Driver (OMD) failures. As a result, the OMD did not create specific...

  6. Field Safety Notice: Applied Medical - VOYANT® Elektrochirurgische Generator06-09-2017

    Applied Medical heeft geconstateerd dat een onjuiste fabricagedatum gedrukt staat op het label dat zich bevindt op de achterzijde van de EA010 Voyant...

  7. Field Safety Notice: Ethicon, Vicyrl Rapide 2-0 and 4-0 Suture Damage04-09-2017

    Ethicon has initiated a medical device recall (removal) of certain lots of VICRYL RAPIDETM (Polyglactin 910) Suture. We have identified that certain lots of sizes 2-0...

  8. Field Safety Notice: Radiometer Medical ApS, AUTOCHECK 5+ level 2 ampoules04-09-2017

    Radiometer has recently become aware of AUTOCHECK 5+ level 2 ampoules, may give incorrect results for pO2.

  9. Field Safety Notice: Abbott - patiënteninformatie diverse pacemakers ihkv cybersecurity04-09-2017

    We willen u informeren over een update van de zogenaamde ‘firmware’ die is geïnstalleerd op uw pacemaker. Het doel van deze update is om uw apparaat nog beter te...

  10. Field Safety Notice: Beckman Coulter - AQUIOS CL Flow Cytometry System01-09-2017

    As a result of internal investigations, BEC has learned that an erroneous configuration setting during servicing may be possible on the AQUIOS CL instruments.