Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. The Spectranetics Corporation D055703 Bridge® Occlusion Balloon

   The Bridge Occlusion Balloon catheter is indicated for use for temporary vessel occlusion of the superior vena cava in ...

   Waarschuwing | 26-03-2020

2. Medtronic FA906 - Pipeline Flex Embolization Device

   Medtronic has identified the potential for device fracture at the distal section during use due to a weakened bond in a subset of ...

   Waarschuwing | 27-02-2020

3. Medtronic Inc. FA889 SynchroMed® II Implantable Infusion Pump

   Bij een permanente motorstop zal de medicamenteuze infusietherapie stoppen, wat kan leiden tot terugkeer van onderliggende ...

   Waarschuwing | 01-10-2019

4. LivaNova USA, Inc., NM-HOU-2019-002 VNS Therapy® SenTiva® Generator

   Unintended device disablement may occur in a small population of Model 1000 generators (Serial Numbers ≥ 100,000) due to a ...

   Waarschuwing | 26-09-2019

5. Natus Medical Denmark DOC-035720 Chartr EP 200

   It has been determined that the device does not fully meet current regulatory standard for basic electrical safety and essential ...

   Waarschuwing | 31-07-2019

6. Microtek Medical Ltd. ECL-FSCA-138 - Intraoperative Probe Cover with Long Surgi-Tip

   Er is een zeer kleine kans op bacteriële contaminatie van een aantal batches van de intra-operatieve sondehoes. Ecolab heeft ...

   Waarschuwing | 19-07-2019

7. Edwards FCA-134 - IntraClude Intra-Aortic Occlusion Device

   Als de IntraClude ballon tijdens de cardiopulmonale bypassoperatie barst, kan het hart vullen en warm worden, de operatieplek kan ...

   Waarschuwing | 12-07-2019

8. Electromedical Products International (EPI)_MEDIMARK - Alpha Conducting Solution

   The product may not have the capability to effectively control the contamination of the conducting solution over time. The ...

   Waarschuwing | 09-07-2019

9. Natus Medical_Otometrics - ICS Chartr EP 200

   It has been determined that the device does not fully meet current regulatory standard for basic electrical safety and essential ...

   Waarschuwing | 17-06-2019

10. Ad-Tech Medical 11-06-2019-00001 - Cortical Electrode, Depth Electrode, Anchor Bolt

    Ad-Tech Medical Instrument Corporation is recalling supplemental information that may have been sent to customers in response to ...

    Waarschuwing | 11-06-2019