Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Spectranetics Corp., 2024-IGT-IGTD-004, Turbo Elite Laser Atherectomy Catheter

   Philips heeft een potentieel veiligheidsprobleem ontdekt met een beperkt aantal Turbo-Elitelaseratherectomiekatheters waarbij de ...

   Waarschuwing | 09-12-2024

2. Cook Endoscopy/Wilson Cook Medical, Inc., 2024FA0007, Hemospray Endoscopic Hemostat

   Cook Medical has identified that a limited number of nonconforming raw materials were manufactured into certain lot numbers of ...

   Waarschuwing | 07-11-2024

3. Covidien IIc, FA1355, Palindrome Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8 mm) x 23 cm

   Bij analyse na het in de handel brengen werd vastgesteld dat bij sommige kathetersets in vier (4) specifieke loten van de ...

   Waarschuwing | 28-08-2023

4. Cook Endoscopy.Wilson Cook Medical Inc., 2023FA0006, Hemospray Endoscopic Hemostat

   Adhesion of the powder to the endoscope or endoscope to the tissue can result in delay in treatment, mucosal tear, perforation, ...

   Waarschuwing | 31-05-2023

5. Siemens Healthcare GmbH, FSN-AX033/21/S (FSN/Addendum) AXIOM Sensis XP/ Sensis/ Sensis Lite/ Vibe Combo

   We would like to inform you about a potential issue with your AXIOM Sensis XP, Sensis/Sensis Lite or Sensis Vibe Combo system and ...

   Waarschuwing | 23-08-2022

6. Mölnlycke Health Care, 2022-05(02), Mölnlycke Procedure Trays

   De reden voor deze terugroeping is dat Blink Medical een klacht heeft ontvangen over het niet goed functioneren van retractors ...

   Waarschuwing | 22-06-2022

7. Synovis Life Technologies, FA-2022-011, Flo-Thru Intraluminal Shunt

   Baxter Healthcare Corporation is issuing a Recall to the user level for one lot of Flo-Thru Intraluminal Shunt listed below due ...

   Waarschuwing | 22-04-2022

8. Acandis GmbH FSCA 22-001 - DERIVO® 2 Embolisation Device

   We have received an increasing number of complaints from customers who have reported difficulty in delivery of devices through ...

   Waarschuwing | 26-01-2022

9. Siemens AX044_20_S - Sensis Vibe Hemo systems with MicroPod™ EtC02

   We already informed you by our notification AX048/20/S about the MicroPod EtCO2 issue. Following this information, we inform you ...

   Waarschuwing | 31-07-2020

10. Cook Endoscopy, Wilson-Cook Medical Inc. 2020FA0002 - Hemospray Endoscopic Hemostat

    Cook Medical has received complaints regarding Hemospray Endoscopic Hemostat devices for the handle and/or activation knob ...

    Waarschuwing | 13-02-2020