Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. lsiomedicca Medizinprodukte GmbH, FSN-IINC-AT-20-02-000002, Anti C4d

   lsiomedicca Medizinprodukte GmbH would like to inform you that the antibody from this specific anti-C4d Antibody lot (# RCD191) ...

   Waarschuwing | 26-05-2020

2. Mevion Medical Systems Inc, FSN-FSCA_200521, MEVION S250i Proton Therapy System

   Mevion Medical Systems Inc received a complaint indicated the occurrence of a geometric mistreatment involving a single treatment ...

   Waarschuwing | 22-05-2020

3. Abena A/S FSN 1269554 - Abena Nova with MediSens Clip

   Abena A/S experienced irregularities with the closing function of a clip. Hence, the clip was not tightening appropriately around ...

   Waarschuwing | 19-05-2020

4. Sunrise Medical GmbH, FSN-203200824182745, Quickie Q700 UP M & Quickie Q700 UP F

   Power Wheelchairs Quickie. Tijdens het assemblageproces is een niet goedgekeurde kabelbevestiging geassembleerd.

   Waarschuwing | 14-05-2020

5. Drägerwerk AG & Co. KGaA, FSN-PR 96232, Various (all heated breathing circuits)

   As part of our global product monitoring, Dräger has become aware of a case in which a VentStar Helix heated breathing circuit ...

   Waarschuwing | 08-05-2020

6. Oxoid Deutschland GmbH Thermo Fisher Scientific FSN-2020-005 LEGIONELLA-M.W.Y.-SELEKTIVNÄHRBODEN

   A technical investigation has concluded that contamination may be present within the medium following incubation. There is a risk ...

   Waarschuwing | 07-05-2020

7. NuVasive Inc, FSN-MAGEC-1, MAGEC System

   NuVasive, Inc. voluntarily issues this Urgent Field Safety Notice (FSN) to inform healthcare providers caring for patients with ...

   Waarschuwing | 03-05-2020

8. Philips Medical Systems FSCA 86400034A-IR Pneumograph, chest

   De borstbalg bevat 90-95% natuurlijke rubberlatex in de slang die vanaf de balg tot de draadloze zuurstofsaturatie- ...

   Waarschuwing | 01-05-2020

9. Gebrüder Martin GmbH & Co.KG-A company of the KLS Martin Group, FSN-05121/20, KLS Martin / smartDrive

   The purpose of this safety notice is to inform you about an additional product information initiated by Gebrüder Martin GmbH & ...

   Waarschuwing | 30-04-2020

10. Philips Medical Systems Netherands BV, FSN-2020-IGTPUN-004, Zenition 50, Zenition 70 Systems

    Verlies van trekontlasting in de verbindingskabel tussen het mobiele weergavestation en de C-boogstandaard (Kabel voor de ...

    Waarschuwing | 30-04-2020