Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Thermo Fisher Scientific FSN-2022-004 - Remel Culti-Loops Candida albicans ATCC™ 10231™ PK/5

   An internal technical investigation has confirmed that Remel™ Culti-Loops™ Candida albicans ATCC™ 10231™ PK/5 R4601503 Lot 294388 ...

   Waarschuwing | 13-04-2022

2. Mikrogen GmbH DE/202201 - recomScan Software v3.4 (BLOTrix System)

   With this letter we would like to inform you about a defective version of recomScan 3.4 software for avidity test systems.

   Waarschuwing | 13-04-2022

3. Sol-Millennium Medical, Inc., FSN-3014312726-2/16/15-001-R, SOL-M™ Blunt Fill Needle

   Sol-Millennium heeft een toename vastgesteld van rubberen stoppen van geneesmiddelenflacons die werden uitgehold bij het ...

   Waarschuwing | 08-04-2022

4. Mevion Medical Systems, FSN-FSCA_220209, Mevion S250i

   Mevion was informed of an instance where a user changed only the Setup isocenter in ARIA in a previously approved plan, without ...

   Waarschuwing | 01-04-2022

5. Thermo Fisher Scientific, FSN-2022-001, Remel Culti-Loops E. floccosum ATCC 52066 PK/5

   An internal technical investigation has confirmed that Remel™ Culti-Loops™ E. floccosum ATCC™ 52066™ PK/5 R4601977 Lot 255302 may ...

   Waarschuwing | 31-03-2022

6. Instrumentation Laboratory, 2022_001, HemosIL AcuStar ADAMTS13

   We hebben klachten van klanten ontvangen over resultaten van patiëntmonsters onder de normaal grens van <10% activiteit met de ...

   Waarschuwing | 31-03-2022

7. Hillrom, FA-2021-12-003-BAT-008, Compella Bariatric Bed and Controller

   Tijdens de levensduur van het Compella bed en de Compella luchttoevoerunit kan het netsnoer beschadigd raken als gevolg van ...

   Waarschuwing | 30-03-2022

8. ARCHEON, FSN-FSCA-2022-N°01, EOlife®, EOlife® Premium Pack

   The conversion to SLM does not consider the expansion of the gas at room temperature and the atmospheric pressure to adjust the ...

   Waarschuwing | 28-03-2022

9. FIAB SpA, FSN-FSCA nr. 139, Pads for Defibrillation "Bexen Cardio"

   The system for connecting the electrodes to the AED consists of a “main body” connector and an “adapter identifier” for pediatric ...

   Waarschuwing | 21-03-2022

10. Zimmer Biomet ZFA 2021-00263 - various implants used in Upper Trauma, Lower Trauma, Foot & Ankle and Sports Medicine surgical procedures (ALPS, DVR, Juggerloc)

    Biomet Orthopedic LLC is conducting a lot specific medical device Field Safety Corrective Action (removal) for various implants ...

    Waarschuwing | 15-03-2022