Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Field Safety Notice: Trinity Biotech - Premier Buffer A_B Reagent

   We are writing to inform you that we have received reports of difficulty in recovering controls (QC verification), using the ...

   Waarschuwing | 23-02-2017

2. Field Safety Notice: Siemens Healthcare, ADVIA® Chemistry Systems

   Siemens Healthcare Diagnostics is providing an update to all ADVIA Chemistry Systems Lactate Dehydrogenase L-P (LDLP) and Lactate ...

   Waarschuwing | 22-02-2017

3. Field Safety Notice: Hitachi High-Technologies Corporation, cobas® 8000 Operator’s Manual version 5.0

   The version 5.0 OM incorrectly states that 11 to 16 mm diameter NSTs may be used on cobas e 602 and cobas e 801 modules. ...

   Waarschuwing | 22-02-2017

4. Field Safety Notice: Schiller Medical - Battery for defibrillator FRED easy

   Users have reported some new batteries causing the failure "BATTERY EMPTY" when inserted. Fabrikant: Schiller Medical Product: ...

   Waarschuwing | 21-02-2017

5. Field Safety Notice: Physio-Control, LIFEPAK 15 apparaat

   Physio-Control heeft kennis genomen van een probleem, waardoor het LIFEPAK 15 apparaat misschien geen defibrillatie-energie kan ...

   Waarschuwing | 21-02-2017

6. Field Safety Notice: HS Hospital Service SpA, RF Amica Probe

   A possible error in packaging can be present on code RFH17200E20V1 lot number 27617 and RFH17150E35V1 HS lot 27616 Fabrikant: HS ...

   Waarschuwing | 20-02-2017

7. Field Safety Notice: Hitachi High-Technologies Corporation, cobas® 8100 automated workflow series

   We regret to inform you that a rack crash may occur on the cobas® 8100 reformatter modules URF and BRF with software versions ...

   Waarschuwing | 20-02-2017

8. Field Safety Notice: Fresenius Medical Care, multiFiltratePRO apparaten

   In de loop van onze 'post-marketing surveillance' activiteiten ontvingen we enkele klantrapportages betreffende observaties dat ...

   Waarschuwing | 20-02-2017

9. Field Safety Notice: Immucor, Capture-R®Ready-ID®

   Further DNA testing of donor D1741 has confirmed the donor as V–, instead of V+ as indicated on the Master List. Fabrikant: ...

   Waarschuwing | 20-02-2017

10. Field Safety Notice: Randox Laboratories - Liquid Cardiac Control

    Randox has confirmed a change in recovery with regard to Myoglobin in the lots of the Liquid Cardiac Control listed above for the ...

    Waarschuwing | 17-02-2017