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  1. Abbott Laboratories, FA19OCT2023 A, Alinity s System

    Precautionary labeling is being added to the Alinity s System to inform the users of the presence of dry natural rubber (latex). ...

    Waarschuwing | 02-11-2023

  2. Cook Endoscopy-Wilson Cook Medical, Inc., 2023FA0009, Quantum TTC Biliary Balloon Dilator

    Cook Endoscopy/Wilson-Cook Medical, Inc. is initiating a voluntary removal of affected QBD devices from the market because they ...

    Waarschuwing | 02-11-2023

  3. Anhui Anyu Latex Products Co., Ltd, AYFSCA2302, Sterile Latex Surgical Gloves, MEDISTOCK brand

    1 product lot concerned from the manufacturer Anhui Anyu Latex Products Co. Ltd, was revealed non-compliance with the sterility ...

    Waarschuwing | 02-11-2023

  4. Olympus Medical Systems Corporation, QIL FY24-EMEA-22-FY24-OMSC-08-BF Burnt Distal End, Flexible video bronchoscope, reusable

    There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the ...

    Waarschuwing | 31-10-2023

  5. Maquet Cardiopulmonary GmbH, 874275, Custom Tubing Packs

    It was reported that there was gas leaking from the cardioplegia line.

    Waarschuwing | 31-10-2023

  6. Biomet Spain Orthopaedics, S.L., Polished Finned 1 Piece Tibial Tray 83 mm

    After investigation, it has been concluded that, the external labeling corresponds with a Polished Finned 1 Piece Tibial Tray 83 ...

    Waarschuwing | 31-10-2023

  7. Siemens Healthcare GmbH, XP056/23/S, XP047/23/S, Luminos dRF/Max;Agile Max;Ysio/Max/X.pree

    Following a complaint, it was identified that during system installation the mounting of the BABIX holder was possibly performed ...

    Waarschuwing | 31-10-2023

  8. Siemens Healthcare Diagnostics Inc., POC 23-018, RAPIDPOINT 500 Blood Gas System and RAPIDPOINT 500e Blood Gas System

    Siemens Healthcare Diagnostics Inc. has determined that two drugs, Perhexiline Maleate and Atomoxetine Hydrochloride, may ...

    Waarschuwing | 27-10-2023

  9. Change Healthcare Canada Company, AN-04482, Change Healthcare Radiology Solutions

    Update messages from Change Healthcare Radiology Solutions (CHRS) may not update patient or study records in external ...

    Waarschuwing | 27-10-2023

  10. Elekta, Ltd, FCA-EL-0017, Linear Accelerator

    Elekta heeft vastgesteld dat als de microschakelaar in de middelste arm onjuist is ingesteld, er een kans bestaat op het ...

    Waarschuwing | 27-10-2023