Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Siemens Healthcare Diagnostics AIMC 22-03 - Atellica® Solution and ADVIA Centaur® Systems

   Siemens Healthcare Diagnostics Inc. has confirmed customer observations of falsely elevated results when using plasma specimens ...

   Waarschuwing | 28-03-2022

2. Getinge Disinfection CAPA 555530 - Getinge 9100-series - Washer Disinfector

   Getinge has discovered that verification of installation is not always documented or the documentation is incomplete and does not ...

   Waarschuwing | 28-03-2022

3. Siemens Healthcare Diagnostics POC 22-002 - Atellica® UAS 800 Urine Sediment Analyzer & Atellica® 1500 Automated Urinalysis System

   Siemens Healthcare Diagnostics has confirmed that the door gas spring which holds the analyzer door open is failing before its ...

   Waarschuwing | 28-03-2022

4. Abbott Molecular FA-AM-MAR2022-269 - Alinity m HBV AMP Kit

   Abbott has received reports of falsely elevated results when using the Alinity m HBV AMP Kit. Data analysis has determined that ...

   Waarschuwing | 28-03-2022

5. SENTINEL FSCA 01/2022 - CALiaGOLD Control Set

   An accuracy issue using Sentinel CALiaGold® Control Set REF 1151200 has been encountered, when testing the control material, ...

   Waarschuwing | 28-03-2022

6. GE Medical Systems, Revolution CT

   De geaccumuleerde dosis wordt verkeerd weergegeven tijdens een interventioneel onderzoek met de SmartStep-optie.

   Waarschuwing | 28-03-2022

7. 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

8. Roche Diabetes Care SB_RDC_2022_02 - RocheDiabetes Care Platform HCP_M

   Roche Diabetes Care became aware of a potential patient data mismatch when using the browser’s “back” button to navigate between ...

   Waarschuwing | 28-03-2022

9. Abbott FA-Q122-CRM-1 - Merlin™ and Merlin™2 Patient Care System (PCS)

   Indien een gebruiker de knop “Hold to Test” indrukt en besluit te stoppen met testen door de knop los te laten voordat de eerste ...

   Waarschuwing | 28-03-2022

10. Merit Medical Systems Inc., FSN-1721504-03/01/22-002R, Access-9™ and AccessPLUS™ Hemostasis Valves

    Merit Medical Systems, Inc. roept vrijwillig de Access-9™- en AccessPLUS™-hemostasekleppen terug vanwege een defect als gevolg ...

    Waarschuwing | 21-03-2022