Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. ITH icoserve technology for healthcare GmbH, FSN-QM-533, syngo.share view diagnostic

   Notice Regarding the Calculation of Slice Thickness for Multiplanar Reconstruction (MPR) in syngo.share view diagnostic.

   Waarschuwing | 10-09-2020

2. bioMerieux Inc, FSN-FSCA 4864, Chocolat PolyViteX (PVX)

   bioMerieux Benelux meldt dringend bericht over productverbetering CHOCOLATE POLYVITEX (Ref. 43109 -43101).

   Waarschuwing | 09-09-2020

3. Olympus Medical Systems Corporation, FSN-QIL 153-009, OES CHOLEDOCHOFIBERSCOPE OLYMPUS CHF TYPE CB30S

   Olympus Medical Systems Corporation (“Olympus”) is writing to inform you of a removal action of all OES CHOLEDOCHOFIBERSCOPE ...

   Waarschuwing | 09-09-2020

4. Vascular Solutions LLC, FSN-PL0252 – Rev. B / HRA00079, Langston Dual Lumen Catheter

   Met deze brief informeert Vascular Solutions LLC, onderdeel van Teleflex, u de reikwijdte van hun vrijwillige terugroeping van de ...

   Waarschuwing | 09-09-2020

5. Olympus Medical Systems Corporation, FSN-QIL 153-010, INTESTINAL VIDEOSCOPE OLYMPUS POWERSPIRAL (PSF-1)

   INFORMATION ON ADVERSE EVENTS OBSERVED DURING POWERSPIRAL (PSF-1) PROCEDURES.

   Waarschuwing | 09-09-2020

6. ThermoFisher Scientific-Microbiology Central Reporting, FSN-FSN-2020-0007, ThermoScientificTM OxoidTM F100 Nitrofurantoin

   A technical investigation has confirmed that some packs of Thermo Scientific™ Oxoid™ F100 Nitrofurantoin CT0034B Lot 2961028 may ...

   Waarschuwing | 08-09-2020

7. Gentian AS CC-167 - Gentian Cystatin C Calibrator and Calibrator Kit

   The identified lots of calibrators have shown to measure incorrect high values over time compared to the assigned values when ...

   Waarschuwing | 02-09-2020

8. Micro Therapeutics Inc. DBA ev3 Neurovascular, FSN-FA929, PipelineTM Flex Embolization Device (with Shield TechnologyTM)

   Medtronic is providing this notice regarding a labeling update to ensure awareness among Pipeline™ Flex and Pipeline™ Flex with ...

   Waarschuwing | 02-09-2020

9. PAUL HARTMANN AG, FSN-10001017624, Tela® products, Longuetten and corresponding procedure trays (CombiSet®)

   The listed Tela® products and Longuetten are gauze products containing an interwoven x-ray detectable thread. The listed ...

   Waarschuwing | 01-09-2020

10. intra special catheters GmbH FSCA200001 - PNEUMOCATH®_NEO-PNEUMOCATH®_THORACATH®-models

    The background to the corrective action is an incident reported by a user concerning the product "Neo­Pneumocath for adults 10F - ...

    Waarschuwing | 01-09-2020