Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Radiometer Medical ApS, FSN-FAN 915-419, ABL700/ABL800 FLEX Analyzer

   Radiometer has become aware of a potential issue with ABL700 analyzers configured to report cNa+. We have received sporadic ...

   Waarschuwing | 13-05-2022

2. BAAT Medical Products, CAPA 583, GANNET Implants

   A review of the technical documentation of the GANNET Implant has shown incorrect warnings displayed on the Instructions for Use ...

   Waarschuwing | 20-04-2022

3. ARCHEON, FSN-FSCA-2022-N°01, EOlife®, EOlife® Premium Pack

   The conversion to SLM does not consider the expansion of the gas at room temperature and the atmospheric pressure to adjust the ...

   Waarschuwing | 28-03-2022

4. Philips Medical Systems FSN-2021-CC-HPM-074 - Esophageal_Rectal_Skin Temperature Probes

   The Esophageal/Rectal/Skin Temperature Probe’s Instructions for Use, (IFU), contain inadequate instructions related to the ...

   Waarschuwing | 10-02-2022

5. Skulle Implants Oy, FSN-22001, GLACE™ Custom Made Craniomaxillofacial Implant

   Skulle Implants heeft de overgangsbepalingen van de MDR (artikel 120) onopzettelijk verkeerd geïnterpreteerd. De conformiteit van ...

   Waarschuwing | 10-02-2022

6. SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD., FSN-FSCA-22/01, Inflation device

   KDL heeft Medline meegedeeld dat de zuigplunjer niet sterk genoeg is, waardoor deze tijdens het opblazen kan breken. Als de ...

   Waarschuwing | 01-02-2022

7. WelchAllyn FA 2021-12-001-MKE-004 - Qstress_Xscribe, Hscribe_Vision Exp, DCS, ConnexCa

   Hillrom is zich bewust geworden van de kwetsbaarheid in de software van de bovengenoemde apparaten, waardoor elke gebruikersnaam ...

   Waarschuwing | 27-01-2022

8. MicroPort Scientific Coöperatief, MSC_FSCA21110002, PROCOTYL P SUPERPATH IMPACTOR ADAPTOR

   MicroPort has been made aware of 7 total incidents involving intra- operative complications due to jamming of the PROCOTYL® P ...

   Waarschuwing | 14-12-2021

9. DIXI Medical S.A.S., FSN-FDS MED 3130, MICRODEEP Depth Electrode

   This is to inform you that DIXI Medical S.A.S. has initiated a voluntary Field Safety Corrective Action (FSCA) of the MICRODEEP® ...

   Waarschuwing | 14-12-2021

10. Eco-Med Pharmaceutical, EcoGel 200

    We are instructing you to immediately stop using and discard all coupling gels manufactured by Eco-Med Pharmaceutical Inc. due to ...

    Waarschuwing | 05-12-2021