Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. ADRIA S.R.L., FSN-01/ 2021, vedi elenco allegato

   Deze veiligheidswaarschuwing maakt onderdeel uit van een groter Europees onderzoek naar vervalste certificaten. Doordat de ...

   Waarschuwing | 26-05-2021

2. HemoSonics LOT 3000000028 KT-0010 - QPlus® Cartridges

   The purpose of this notification is to inform you that HemoSonics, LLC has identified a potential issue with this specific lot of ...

   Waarschuwing | 26-05-2021

3. Siemens Healthcare AX063_20_S - Artis pheno systems with SW VE10B

   In case of a fault within the drivetrain of an axis and while performing a stepped peripheral imaging PERISTEPPING/PERIVISION), ...

   Waarschuwing | 26-05-2021

4. Philips Medical Systems Nederland B.V., FSN-FSCA 72800752/88200531, CT Fluoroscopy Digital Video Interface (DVI) Package with Ceiling Mounted Portegra2 Extension/Spring Arm by Mavig

   URGENT veiligheidsbericht: Plafondbevestiging voor continue CT-fluoroscopie DVI - optie voor DVI CCT-arm - monitorsteun. ...

   Waarschuwing | 26-05-2021

5. IBA (Ion Beam Applications), FSN-PR 118823, ProteusPLUS

   Urgent Field Safety Notice Regarding Proteus235: The Proton Therapy System does not prevent irradiation if the user forgets to ...

   Waarschuwing | 25-05-2021

6. Philips Medical Systems Nederland B.V., FSN-FSCA FCO781 00524, Ingenia Ambition X, Ingenia Ambition S

   URGENT veiligheidsbericht Ingenia Ambition X, Ingenia Ambition S: Probleem met mechanische afmetingen van hijsblokken boven op de ...

   Waarschuwing | 25-05-2021

7. The Binding Site Group Limited, FSN-AE056, Freelite Human Kappa Free Kit on Roche Cobas

   Positieve bias met invloed op de kwaliteitscontroles van de Freelite Human Kappa Free Kit on Roche Cobas.

   Waarschuwing | 21-05-2021

8. Amann Girrbach AG, FSN-CAPA Nr.62, Ceramill Zolid FX ML

   Amann Girrbach AG want to inform you about the possibility of a contamination of the blanks in the batches of Zolid FX Multilayer ...

   Waarschuwing | 20-05-2021

9. Thermo Fisher Scientific-Microbiology Central Reporting, FSN-2021-0003, ARIS HiQ

   Urgent Field Safety Notice ARIS HiQ: Low resistance heaters.

   Waarschuwing | 20-05-2021

10. Randox Laboratories Ltd, FSN-REC527, Randox NEFA (Non-esterified fatty acid)

    Randox can confirm the NEFA standard 522FA packed within NEFA kit Catalogue Number FA115 Batch 544642 has been assigned ...

    Waarschuwing | 20-05-2021