Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Covidien llc, FSN-FA967, 178083: Surgiwand™ II Auto Suture™ Suction and Irrigation Device 5mm/with L-Hook Tip 5mm/ Spatula 5mm

   The purpose of this letter is to advise you that Medtronic is voluntarily recalling specific production lots of its Covidien ...

   Waarschuwing | 24-03-2021

2. Coloplast A/S, FSN-FSCA_Elefant_20200903, ELEFANT® Suction/irigation device

   Urgent Field Safety Notice ELEFANT® SUCTION/IRRIGATION DEVICE for Specific lots.

   Waarschuwing | 15-09-2020

3. KARL STORZ SE & Co. KG-23-0015, BEYER Antrum Punch, Antrum Punch, Sphenoid Punch, Sphenoid Punch, Sphenoid Punch, Galea Spring Hook, Uvula Retractor, Optical Biopsy and Grasping Forceps, Grasping Forceps, Optical Scissor, Working Insert with steering lever

   It was found that there is not insufficient evidence to show that the reprocessing method of the products was adequately ...

   Waarschuwing | 04-01-2024

4. GE Healthcare FMI 85464 - Centricity Universal Viewer Zero Footprint Client (ZFP)

   GE Healthcare heeft kennis genomen van een kwestie waarbij de waarden voor afstand en oppervlakte onnauwkeurig weergegeven kunnen ...

   Waarschuwing | 13-07-2022

5. Olympus QIL 154-020 - DISPOSABLE GRASPING FORCEPS FG-51D and FG-55D

   Olympus has received complaints that the grasping portion of FG-51D and FG-55D forceps can be difficult to open and close. ...

   Waarschuwing | 21-04-2022

6. Olympus, QIL 152-007, Bronchoscope

   This quality issue may result in the leakage of the channel tube or the bending section.

   Waarschuwing | 10-12-2019

7. Ethicon Endo-Surgery LLC, FSN-ECHELON FLEX™ Powered Plus Stapler, Powered Plus Articulating Endoscopic Linear Cutter

   DRINGENDE VEILIGHEIDSINFORMATIE: ECHELON FLEX™ Powered Plus Stapler: product code PSEE60A, lot U94V47. Vrijwillige terugroepactie ...

   Waarschuwing | 03-06-2021

8. Coloplast FRGNY-2017-1009-AEBD35 - Duowire™ Bi-Flex voerdraad

   Er is geconstateerd dat bij gebruik, in met name urologische procedures, het risico bestaat dat bepaalde delen van de distale ...

   Waarschuwing | 16-10-2017

9. Intuitive Surgical Inc 2955842-07/14/16-010-R - IS4000 EndoWrist Stapler 45, IS4000 EndoWrist Stapler 30, IS4000 EndoWrist Stapler 30 Curved-Tip

   This recall follows from a field failure where the stapler remained clamped on tissue, even when the Stapler Release Kit was ...

   Waarschuwing | 03-11-2016

10. Covidien LLC Clearify Visualization 10/16 - Clearify Visualization System

    This Field Safety Corrective Action (FSCA) is being conducted due to the potential for compromise of the package resulting in a ...

    Waarschuwing | 07-10-2016