Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. EMPATICA S.R.L., CAPA-0000021, EMBRACE2

   Eenmaal volledig opgeladen, gaat de batterij van het Embrace-apparaat naar verwachting 48 uur mee, op voorwaarde dat het apparaat ...

   Waarschuwing | 17-10-2023

2. Ace-medical Quality Management Dept., 202307-08-FSCA, AutoMer 2

   AutoMer 2 (A230214-E2MZ0000AT-1 was returned as a complaint device. Through the tests, Ace Medical found a problem with a ...

   Waarschuwing | 28-09-2023

3. Olympus Medical Systems Corporation, QIL FY24-EMEA-17-FY23-OMTA-43, Olympus Flexible Endoscopes with channels

   Olympus discovered that our channel air drying process was not validated, and that a small percentage of scopes returned to ...

   Waarschuwing | 25-09-2023

4. Chromsystems Instruments & Chemicals GmbH, CAPA 08-2023, MassCheck(R) Drugs of Abuse Testing Urine Control Level I

   Recente stabiliteitsstudies spreken de informatie in de bijsluiter van Lot 0623 tegen. De volgende tabel toont de juiste ...

   Waarschuwing | 12-09-2023

5. Invivoscribe, Inc., 3014173060-07-18-23-003-C, LymphoTrackDx IGH - MiSeq

   The impacted master mix lots, when used to amplify clinical samples, will not produce amplification of the VH7 region. In the ...

   Waarschuwing | 28-08-2023

6. Medion Grifols Diagnostics AG, 800012088, Screen-Cyte 0.8%

   During our routine vigilance process, it has been detected that a small subset of kits (13 kits in total} of the three-cell ...

   Waarschuwing | 14-08-2023

7. Gebruder Martin GmbH and Co.KG, CPL0604, SD-blade F.5 2.0 2.7MM PHILIPS

   De traceerbaarheid van de producten is niet gegarandeerd. Bovendien kan het onjuist verpakte product leiden tot verwarring ...

   Waarschuwing | 27-07-2023

8. Canon Medical Systems Corporation, FSN-COM-0000000990, UltraExtend NX

   Bij gebruik van de functie “Worksheet” op de hierboven genoemde systemen worden in zeldzame gevallen de meetwaarden van de vorige ...

   Waarschuwing | 17-07-2023

9. Gynemed GmbH & Co. KG, FSN-Denu-Tips, Denu Tips und Oocyte aspiration Needles

   During a recent supplier audit, our supplier was unable to provide adequate documentation of the required testing and raw ...

   Waarschuwing | 20-02-2023

10. Surgical Innovations Ltd., FSN-FSN 22-001, YelloPort Elite Universal Seal

    Surgical Innovations have identified that, during the manufacturing process, there is a risk of the formation of a hole in the ...

    Waarschuwing | 29-11-2022