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  1. Electromedical Products International (EPI)_MEDIMARK - Alpha Conducting Solution

    The product may not have the capability to effectively control the contamination of the conducting solution over time. The ...

    Waarschuwing | 09-07-2019

  2. Skulle Implants FSN0719 - GLACE Screws 6 mm

    Skulle Implants Corporation is conducting a medical device Field Safety Corrective Action for the GLACETM CMF 6 mm screws due to ...

    Waarschuwing | 08-07-2019

  3. Zimmer, Inc - ZFA 2019-00062 - Pulsavac Plus Wound Debridement System

    Zimmer Surgical, Inc. is conducting a medical device Field Safety Corrective Action (removal) for lot specific Pulsavac® Plus ...

    Waarschuwing | 08-07-2019

  4. Randox Laboratories Ltd - REC395 - Calibration Serum Level 3

    Randox have realigned the RX Analyser Series calibration t argets by 10% for AST and 9% for ALT in line with the Mean of All ...

    Waarschuwing | 05-07-2019

  5. SHENZHEN MINDRAY CP1812-JH00380 - BeneHeart D1

    Het potentiële probleem kan worden veroorzaakt door de interne draad naar de defibrillatoraansluiting die wordt gebruikt op de ...

    Waarschuwing | 05-07-2019

  6. MESI 05_07_2019 - Automated Ankle-Brachial Index measuring device (MESI ABPI MD)

    After recently performed calibrations of the ABPI MD, our UK distributor noticed that the cuffs are overinflating. This does not ...

    Waarschuwing | 05-07-2019

  7. Elekta FCA-IMS-0031- Monaco RTP System

    Monitorunits kunnen onjuist zijn bij het volgen van een specifieke workflow in Monaco®.

    Waarschuwing | 04-07-2019

  8. Roche Diagnostics GmbH- CN-437494 - Elecsys Anti-CCP

    We wish to inform you that Roche has received a number of reports of performance issues with certain lots of the Elecsys Anti-CCP ...

    Waarschuwing | 03-07-2019

  9. B. Braun Medical B.V. FSCA-2019-07-02 SK/AS - Anaesthesia conduction filter

    During the production it was identified that the membrane in the Perifix filter may not fulfil the specified requirements. The ...

    Waarschuwing | 02-07-2019

  10. Eurovema Mobility AB 6.6.2-2019-47648 Euroflex work chairs with Forma chassis

    Eurovema Mobility has discovered, that the screw that holds the chassis halves together on the older work chairs, can loose with ...

    Waarschuwing | 02-07-2019

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