Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.586 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Welch Allyn, Inc., FA-2024-017, PROBP 3400, SPOT VISION SCREENER
Baxter issued a Correction letter for the power cords used with the Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device ...
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MAQUET Cardiovascular LLC, 1124877, Acrobat-i and Acrobat SUV Stabilizer/Positioner
On 7 August 2024, the contract manufacturer (located in Suzhou, China) of the Acrobat product family (see product codes in above ...
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LivaNova Deutschland GmbH, FA-CP-MUN-2024-004, ESSENZ HLM
LivaNova heeft meldingen ontvangen van de grafische gebruikersinterface (‘Graphical User Interface’, GUI) van de cockpit van de ...
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PharmaPartners B.V., ITSM3020231, Pharmacom
Door een fout in de software was het onder specifieke omstandigheden mogelijk dat elektronische recepten die waren binnengekomen, ...
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Mint Medical GmbH, Incident-0011 (FSCA), mint Lesion
The malfunction is caused by a software error that is present in product versions 3.8.6, 3.9.0, 3.9.1, 3.9.2.
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Becton Dickinson, IDS-25-5176, BD BACTEC™ Blood Culture System
BD’s cybersecurity monitoringtools en -processen hebben onlangs ongeautoriseerde toegang geïdentificeerd tot een beperkt deel van ...
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ORGENTEC Diagnostika GmbH, FSCA_2024_01,Alegria 2
Following internal investigation of Alegria 2, it has been confirmed that Alegria 2 instrument with the latest released software ...
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PRIMA Lab SA, 2024-01, Kruidvat URINEWEGINFECTIE ZELFTEST
Het product wordt door de fabrikant verpakt in drie talen: Nederlands, Frans en Duits. Er is gewezen op een inconsistentie in de ...
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GS Elektromedizinische Geräte G. Stemple GmbH, CAPA-5262, Battery corpuls aed
We are observing in the field a certain number of devices that perform an unplanned restart with self-test during operation. The ...
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Siemens Healthcare Diagnostics Products Limited, IMC 24-03, IMMULITE® 2000 PSA
Siemens Healthineers has confirmed, through the investigation of customer complaints, that the IMMULITE® 2000 PSA assay for use ...