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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.

To search by manufacturer’s name or product name, enter the name in this search field.

  1. Field Safety Notice: Greatbatch Medical - MOBICATH™ Bi-Directional Guiding Sheath15-02-2017

    Greatbatch has received reports that one side of the pouch may not be sealed and as result, may cause the sterile barrier of the pouch to be compromised.

  2. Field Safety Notice: ELLA-CS - Danis Procedure Pack (Basic)14-02-2017

    Based on analysis of a returned product, company ELLA-CS, s.r.o. has identified that an unintended movement of the safety valve of the fixation - gastric balloon of the...

  3. Field Safety Notice: Beldico SA, Steriele zuigflessen, spenen en afkolfsets voor eenmalig gebruik11-02-2017

    Sommige producten van het gamma zuigelingenflessen en afkolfsets ETO gesteriliseerd waarvan de ontgassingsperiode nog niet volledig teneinde was onderweg zijn of reeds...

  4. Field Safety Notice: DiaMed GmbH, ID-DiaCell's 10-02-2017

    We would like to share with you, and your team, information about unexpected reactions primarily on eluates and QC samples but also with some patient samples when...

  5. Field Safety Notice: Abbott Vascular, StarClose SE Vaatdichtingssysteem 10-02-2017

    Bij producten van de geïdentificeerde lotnummers kan de StarClose SE Clip mogelijk moeilijk of niet geplaatst worden.

  6. Field Safety Notice: Codman US, Codman Microcoil Delivery Systeem en Detachment Control Boxes (DCB000001-20 & DCB00000500)09-02-2017

    Dit veiligheidsbulletin wordt verstrekt omdat wanneer de nieuwe producten zijn geïntroduceerd er risico’s zijn bij een gelijktijdig gebruik van de huidige en nieuwe...

  7. Field Safety Notice: MicroPort Orthopedics - BIOLOX FORTE 36mm Alumina ceramic heads08-02-2017

    Implants will be updated with a label which will state the numerical offset of the ceramic head instead of the current labelling (Short, Medium, Long).

  8. Field Safety Notice: Iris International (IRIS), iChemVELOCITY08-02-2017

    Iris International has determined that sample probe misalignment or bending on the iChemVELOCITY may lead to a remote possibility of false negative results due to...

  9. Field Safety Notice: Siemens Healthcare, ADVIA® Centaur XPT08-02-2017

    Siemens Healthcare Diagnostics has identified the issues described in Table 2 for all the ADVIA® Centaur XPT system software versions V1.0.1...

  10. Field Safety Notice: B. Braun Surgical, Bone Wax Stick08-02-2017

    Some samples of Bone Wax Stick failed in the five years real time packaging stability studies.