Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Cordis Corporation, FSN-Cordis20210216-CE, PRECISE PRO RX™ Carotid Stent System

   The purpose of this communication is to inform you that Cordis is recalling (removing) specific lots of Cordis PRECISE PRO RX™ ...

   Waarschuwing | 16-02-2021

2. Stereotaxis, Inc., FSN-Stereotaxis ref CT-20-00324; MDSS ref MDD20.273, Niobe ES

   A SATA cable in the Niobe computer cabinet was designed in a way that could lead to electrical arcing.

   Waarschuwing | 13-10-2020

3. Stryker PFA 2438233 - Osteosynthesis Compression Staple EasyClip

   The purpose of this notification is to advise you that Stryker Trauma GmbH (Trauma & Extremities Division) has identified a risk ...

   Waarschuwing | 23-09-2020

4. William Cook Europe ApS, FSN-2020FA0005, Zenith Alpha® Abdominal Endovascular Graft

   Cook Medical has identified that specific lots of the Zenith Alpha® Abdominal Endovascular Graft (21MB main body) may contain ...

   Waarschuwing | 10-08-2020

5. Stereotaxis, Inc, FSN-Stereotaxis ref: CT-19-00613 MDSS ref: MDD20.113, Niobe ES

   It was reported that during a VT ablation procedure done on 8/30/2019, something was set on the keypad, pressing down one of the ...

   Waarschuwing | 08-05-2020

6. Neovasc Inc. FCA 19-001-C - Neovasc Reducer

   Neovasc has discovered an error in the expiration date of the Reducer System Lot No. 190131-01. Since the Reducer Kit expiration ...

   Waarschuwing | 18-02-2020

7. Cordis Corporation Cordis20191113-OUS - PRECISE, S.M.A.R.T., S.M.A.R.T. Control

   Cordis became aware that the Instructions for Use (IFU) for the S.M.A.R.T. and PRECISE stents do not have correct language around ...

   Waarschuwing | 13-11-2019

8. Euros FSCA-2019-01 - E. SPINE TANIT - Iliosacral Connector

   Further to a customer complaint, it was found that few units of Sterile lliosacral connector of the batch mentioned above may ...

   Waarschuwing | 25-10-2019

9. Ad-Tech Medical 22-08-2019-00001 - Drill Sleeve Guide

   On August 22, 2019, Ad-Tech Medical Instrument Corporation decided to voluntarily recall all drill sleeve guides which are ...

   Waarschuwing | 22-08-2019

10. Stryker Spine - Leesburg RA2018-2093200 MESA 2 Deformity Polyaxial Screw; Size Ø6.5x45 mm

    A single lot of MESA 2 Deformity Polyaxial Screws was packaged with the incorrect Instructions for Use (IFU). Instead of the ...

    Waarschuwing | 05-08-2019