Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Welch Allyn, Inc, FA-2023-055, Qstress 6, Xscribe 6

   Baxter Healthcare Corporation is issuing a Correction for the Q‐ Stress and XScribe Cardiac Stress Testing Systems (Q‐Stress ...

   Waarschuwing | 15-12-2023

2. Atrium Medical Corporation, 3011175548-08.18.2023-001-C, Atrium Ocean Water Seal Chest Drains

   The Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution ...

   Waarschuwing | 03-10-2023

3. Teleflex Malaysia Sdn Bdh, Malaysia, FSN-EIF-000478, PERCUQUICK ONE-STEP SET, PDT+PERCUQUICK ONE-STEP DILATOR

   Teleflex has initiated a voluntary Field Safety Corrective Action for Percuquick One Step Set, PDT and Percuquick One-Step ...

   Waarschuwing | 16-07-2021

4. Intersurgical Ltd CAPA 226766 - Nebulizing system delivery set.Anaesthesia breathing circuit.Ventilator breathing circuit.Catheter mount.Anaesthesia face mask

   We have received complaints about cracked ports in the swivel elbow where the flip cap is inserted, and these cracks leak if they ...

   Waarschuwing | 15-07-2019

5. Teleflex Medical, FSN-23/08, Hudson RCI® AQUAPAK® Humidifier Adaptors

   Teleflex Medical Europe, LTD heeft een veiligheidswaarschuwing uitgegeven voor AQUAPAK® bevochtigingsadapters vanwege meldingen ...

   Waarschuwing | 11-09-2023

6. Olympus Medical Systems Corporation, QIL FY24-EMEA-06-FY24-OMSC-04c, BF-Series Endoscopes

   Olympus has received complaints of endobronchial combustion during therapeutic procedures using lasers or argon plasma ...

   Waarschuwing | 21-07-2023

7. Remote Diagnostic Technologies, 2022-CC-EC-017, Tempus Pro Patient Monitor

   However, testing revealed that the device does not meet the standards for Fluid and Particulate lngress.

   Waarschuwing | 08-03-2023

8. Philips Medical Systems, FSCA 2022-CC-HPM-051, MR Patient Care Portal 5000

   During manufacturing inspection of the MR Patient Care Portal 5000, it was discovered that two (2) Portal 5000 units would ...

   Waarschuwing | 22-09-2022

9. Maquet Cardiopulmonary GmbH, FSN-FSCA-2020-07-30, Blood Monitoring Unit BMU 40

   It has become known to Maquet Cardiopulmonary GmbH that the printed circuit board (PCBA Connector) of the BMU40 was designed with ...

   Waarschuwing | 18-09-2020

10. GE Medical Systems Information Technologies, Inc.,FMI 36145 Carescape One

    The CARESCAPE ONE monitor may lose ECG parameter and waveform data when used in conjunction with an Automated External ...

    Waarschuwing | 30-04-2020