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  1. NRT X-Ray A.S, FSCA_PR20230201-01, Intelli-C

    This FSN is distributed to inform users about a risk that a driveshaft in the IDE movement may break, which may lead to ...

    Waarschuwing | 31-05-2023

  2. Cook Endoscopy.Wilson Cook Medical Inc., 2023FA0006, Hemospray Endoscopic Hemostat

    Adhesion of the powder to the endoscope or endoscope to the tissue can result in delay in treatment, mucosal tear, perforation, ...

    Waarschuwing | 31-05-2023

  3. Draeger Medical Systems Inc., PR129416, Softbed Resuscitaire with Scale

    During the course of our global market surveillance activities, we have become aware of cases in which the Resuscitaire Infant ...

    Waarschuwing | 31-05-2023

  4. SCILO Vertriebs GmbH, 004.2023, Inzision-Instrument 70 mm

    SCILO has currently received a complaint from a user about soiling or discolouration on the round, transparent incision template.

    Waarschuwing | 31-05-2023

  5. Armstrong Medical Ltd, SI22-170, AQUAVENT NEO neonatal CPAP limb heated

    A report has been made to Armstrong Medical of tubing (and a connector attached to the tubing) disconnecting from the elbow ...

    Waarschuwing | 31-05-2023

  6. Siemens Healthcare Diagnostics Inc, ACHC 23-03, Atellica CH Toxicology Calibrator

    Siemens Healthcare Diagnostics Inc. received customer complaints regarding a positive bias for the Atellica CH Salicylate (Sal) ...

    Waarschuwing | 31-05-2023

  7. Phadia AB, QA2023-05, EliA GBM Well

    Several customer complaints have been reported where specific samples produced false positive EliA GBM results. An investigation ...

    Waarschuwing | 31-05-2023

  8. Roche Diagnostics GmbH, SBN-RDS-CoreLab-2023-003, aPTT, aPTT Lupus, aPTT Screen

    During internal measurements, carryover from PT Rec and PT Rec-based factor assays (FII, FV, FVII, FX) to aPTT assays (aPTT, aPTT ...

    Waarschuwing | 31-05-2023

  9. SENTINEL CH. S.p.A., 01.2023, CALiaGold Calibrator Control Set Sample Diluent

    Based on the data collected from some customer sites, a high recovery of CALiaGold Control Set IREFj 1151200 may be found.  

    Waarschuwing | 31-05-2023

  10. Philips Medizin Systeme Boblingen GmbH, FSCA 2023-CC-HPM-006, Patient Information Center iX

    Philips has become aware of a potential compliance issue with the Philips Patient Information Center (PIC iX) and IntelliVue MX40 ...

    Waarschuwing | 25-05-2023

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