Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Field Safety Notice: Air Liquide Medical Systems - Ventilatoren Monnal T50

   n het kader van ons toezicht na het in de handel brengen van onze producten, hebben we echter meerdere gevallen van ...

   Waarschuwing | 07-04-2017

2. Field Safety Notice: Autonomic Technologies - Pulsante SPG Microstimulator System

   A change was made to the Pulsante® SPG Microstimulator (the implantable component) which was not properly validated. This change ...

   Waarschuwing | 07-04-2017

3. Field Safety Notice: Boston Scientific - Jetstream Atherectomy Catheters

   Boston Scientific is initiating a voluntary removal of two lots of JETSTREAM SC 1.85mm and one lot of JETSTREAM XC 2.1mm ...

   Waarschuwing | 06-04-2017

4. Field Safety Notice: CardioTek - EP-TRACER

   During product testing it was discovered that the parameters for backup pacing can be changed unintentionally by activating ...

   Waarschuwing | 06-04-2017

5. Field Safety Notice: bioMérieux - Etest ETP32 (Ertapenem)

   Based on the strain epidemiology evolution with the detection of some Streptococcus resistant strains from clinical specimens ...

   Waarschuwing | 05-04-2017

6. Field Safety Notice: Helena - Cascade Abrazo c-ACT-LR cards

   Some cards in this lot have shown occasional shorter or longer clot times than expected variation, as evidenced investigation by ...

   Waarschuwing | 05-04-2017

7. Field Safety Notice: Newport_Medtronic - Newport™ HT70 (Plus) Ventilators

   The purpose of this letter is to advise you that Medtronic is issuing a Field Safety Corrective Action (FSCA) for all its ...

   Waarschuwing | 05-04-2017

8. Field Safety Notice: Siemens - Acuson S Family Ultrasound System

   When scanning with the 18L6 HD transducer on the ACUSON HELX™ Evolution with Touch Control, the ultrasound system may display a ...

   Waarschuwing | 05-04-2017

9. Field Safety Notice: St Jude Medical_ Abbott - Merlin@HomeTM Software

   St. Jude Medical, een dochteronderneming van Abbott Laboratories, heeft onlangs in de Europese Unie CE-goedkeuring gekregen voor ...

   Waarschuwing | 03-04-2017

10. Field Safety Notice: Beckman Coulter, Synchron Systems Cholesterol, Creatinine, HDL Cholesterol, Lactate, Triglyceride, Uric Acid and Salicylate Reagents

    Beckman Coulter has identified the following drugs as potential sources of interference... Fabrikant: Beckman Coulter Product: ...

    Waarschuwing | 03-04-2017