Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. MICROVENTION EUROPE SARL, FSN-FCA2021-01, PHIL-Liquid Embolic

   MicroVention has initiated a voluntary Field Safety Corrective Action for PHIL products packaged in recently introduced tray ...

   Waarschuwing | 12-02-2021

2. Maquet Cardiopulmonary GmbH, FSN-FSCA-2021-02-03, Heater-Cooler Unit HCU 40

   Cancelation of “FSCA-2020-08-06 HCU 40 Replacement of vacuum valves”, Reverse the conversion of updated HCU 40 systems by valve ...

   Waarschuwing | 05-02-2021

3. Medtronic Inc., FSN-FA951, specific subset of ICDs & CRT-Ds experiencing potential

   Via deze brief informeert Medtronic u over een mogelijk probleem bij een subset van implanteerbare cardioverter-defibrillators ...

   Waarschuwing | 02-02-2021

4. Draeger Medical Systems, Inc., FSN-PR102871, Infinity Acute Care System (M540)

   The purpose of this letter is to advise you that Dräger is issuing a voluntary field correction for the Infinity Acute Care ...

   Waarschuwing | 25-01-2021

5. Maquet Cardiopulmonary GmbH, FSN-FSCA-2021-01-11, Customized Tubing Sets

   Maquet Cardiopulmonary GmbH became aware of a missing cable tie in the cardioplegia (Plegiox) line to secure the connection ...

   Waarschuwing | 21-01-2021

6. GE Medical Systems (China) Co., Ltd., FSN-FMI 76188, Vivid iq, Vivid T8, Vivid T9

   Onverwachte systeemuitschakeling van Vivid Ultrasound Systems v204 bij gebruik van DICOM-modaliteitswerklijstvelden die ...

   Waarschuwing | 14-01-2021

7. Biosense Webster Inc, FSN-1910146, nGEN™ RF Generator

   Biosense Webster Inc wants to make you aware of an issue they have detected involving the use of the QMODE+™ setting on the nGEN™ ...

   Waarschuwing | 24-12-2020

8. Maquet_Getinge FSCA-2020-12-07 - Pediatric Venous Hardshell Cardiotomy Reservoir

   During verification testing of Pediatric VKMOs and VHKs a potential impairment of the sterile packaging barrier system was ...

   Waarschuwing | 16-12-2020

9. Spacelabs FSCA Sentinel 9 - Model 98200 & 98201 Bad Upgrade

   During upgrade from Sentinel V9 or below to any later version, incorrect comments may be added to existing reports stored in the ...

   Waarschuwing | 15-12-2020

10. Mar-Med MM-FSA-01 - Uni-Cot, Tourni-Cot Universal

    In rare instances, the device may split into two pieces during removal leaving a portion of the device on the patient’s digit. If ...

    Waarschuwing | 04-12-2020