Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. 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

2. 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

3. Field Safety Notice: Abbott Vascular - Absorb (GT1) Bioresorbable Vascular Scaffold

   In samenwerking met de Europese regelgevende agentschappen (bevoegde autoriteiten en onze aangemelde keuringsinstantie (notified ...

   Waarschuwing | 31-03-2017

4. Field Safety Notice: Optimed - sinus-SuperFlex-635

   The details of the label on the packaging do not correspond to the delivered product. The information of the inner label on the ...

   Waarschuwing | 31-03-2017

5. Siemens Healthcare Diagnostics DC 14-09B - Ammonia Flex reagent cartridge

   In September 2014, Siemens Healthcare Diagnostics issued Customer Notification 14-62 that addressed a high rate of “Abnormal ...

   Waarschuwing | 30-03-2017

6. Field Safety Notice: Merit Medical - Medallion®-spuiten

   Merit Medical Systems, Inc. voert vrijwillig een terugroepactie uit van specifieke partijen van de Medallion®-spuiten van 1 ml ...

   Waarschuwing | 29-03-2017

7. Field Safety Notice: Siemens - Dimension Vista® 500 and 1500

   Siemens Healthcare Diagnostics has confirmed that in isolated cases when ECREA is processed immediately after the weekly ...

   Waarschuwing | 29-03-2017

8. Field Safety Notice: Abbott_Thoratec - HeartMate II®-systeemcontroller

   In aanvulling op ons meest recente bericht van september 2015 willen we u hierbij op de hoogte brengen van het feit dat Thoratec ...

   Waarschuwing | 29-03-2017

9. Field Safety Notice: bioMérieux - Etest OX 256

   Based on QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST® OX 256 (OXACILLIN) Foam packaging (Ref. ...

   Waarschuwing | 28-03-2017

10. Field Safety Notice: Intersurgical, Solus Flexible wire-reinforced laryngeal mask airway 2, 2.5,3,4,5

    A manufacturing fault in the tube supplied to Intersurgical for production of the device can result in partial or total occlusion ...

    Waarschuwing | 28-03-2017