Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.582 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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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 ...
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Siemens Healthcare Diagnostics Inc, ACHC 25-01, Atellica CH Reaction Cuvette Segment
Siemens Healthineers has confirmed, through the internal investigation of customer complaints that there is a potential for ...
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Cook Endoscopy/Wilson Cook Medical, Inc., 2024FA0007, Hemospray Endoscopic Hemostat
Cook Medical has identified that a limited number of nonconforming raw materials were manufactured into certain lot numbers of ...
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Pharmapartners B.V., ITSM3101878, Pharmacom
Door een fout in de software is de theoretische einddatum niet goed berekend na het aanpassen van het aantal stuks tijdens de ...
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Philips Respironics, Inc., 2023-CC-SRC-042, BiPAP A40 Pro, BiPAP A40 EFL, BiPAP A30 EFL
Mogelijk vals alarm van hoog intern zuurstofniveau in Philips Respironics BiPAP beademingsapparaat, typen: A40 Pro, A40 EFL, A30 ...