Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Field Safety Notice: AlterG - M320 Product

   A condition was recently reported by one of our distributors in which an M320 unit unexpectedly surged in speed to the maximum ...

   Waarschuwing | 26-06-2017

2. Field Safety Notice: Siemens Healthcare, syngo Workflow MLR using Portal Radiologist

   Due to sporadic synchronization issues within an MLR application internal process, it can fail to return the appropriate data. ...

   Waarschuwing | 23-06-2017

3. Field Safety Notice: EPflex - WiTrac A.S. AAA Wire

   The cm-scaling on the product, which is visible under X-Ray, was mistakenly promoted as measuring instrument. This could have led ...

   Waarschuwing | 23-06-2017

4. Field Safety Notice: Cook - Zenith Alpha™ Thoracale Endovasculaire prothese

   Zoals beschreven in de recente veiligheidskennisgeving (Field Safety Notice) 2017FA0001 van maart 2017 met betrekking tot de ...

   Waarschuwing | 23-06-2017

5. Field Safety Notice: QIAGEN - QIAamp DSP Virus-kit

   Uit onderzoek is gebleken dat het probleem is veroorzaakt door een afwijking van de juiste bewaarcondities. Dit heeft geleid tot ...

   Waarschuwing | 22-06-2017

6. Field Safety Notice: Endologix International Holdings, AFX EndoVascular AAA System

   We wish to provide additional important recommendations for surveillance of patients implanted with AFX STRATA, and to reinforce ...

   Waarschuwing | 22-06-2017

7. Field Safety Notice: Roche - cobas e 411 and Elecsys 2010 analyzer

   We regret to inform you that in very rare cases a software (SW) malfunction in the Sample&Control datafile can occur which may ...

   Waarschuwing | 21-06-2017

8. RaySearch Laboratories, 15483, RayStation

   This notice concerns an issue found with accelerated computation on NVIDIA GPU (Graphics Processing Unit) in RayStation 4.5, ...

   Waarschuwing | 20-06-2017

9. Field Safety Notice: NOVUM PHARMA BV, Biogaze Compressen

   Op bovenvermelde batches staat op de verpakking de vermelding “steriel”. Dit is ten onrechte gebeurd, aangezien een notified body ...

   Waarschuwing | 20-06-2017

10. Field Safety Notice: Sorin Group, Aortacanules

    Na een verbetering van het inspectieproces heeft LivaNova vastgesteld dat er bij sommige aortacanules (RA-1XXX, NA-1XXX) in de ...

    Waarschuwing | 20-06-2017