Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
220 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Arrow International LLC (Subsidiary of Teleflex Incorporated), EIF-000561, FiberOptix Ultra 8 IAB, Ultra 8 IAB, UltraFlex IAB
Teleflex is initiating this voluntary FSCA for the above-mentioned products due to reports indicating an infrequent condition ...
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B.Braun Melsungen AG, FSCA-2024-04-23, EASYPUMP® II LT
Tijdens onze Post Market Surveillance-activiteiten heeft de fabrikant in één geval een aanzienlijke overmatige infusie in de ...
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Karex Industries Sdn. Bhd., FSN-24/03, Endocavity Probe Cover
Following the receipt of a customer complaint, and after investigations by the Legal Manufacturer, Medline has been informed that ...
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Medtronic MiniMed, FA1249, MiniMed 600 and 700 series insulin pump Battery Cap
We’ve previously reached out to you about a potential issue with the battery cap on the MiniMed™ 600 series and MiniMed™ 700 ...
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Smiths Medical, FA2402-03, Cardinal Health Branded Monoject Syringe
Op 20 september 2023 heeft Cardinal Health een productcorrectie voor medische hulpmiddelen uitgevaardigd voor de Monoject ...
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Intuitive Surgical, Inc., ISIFA2024-02-R, SureForm45/60, Cannula Seal, Arm Drape, Obturator
Intuitive is tot de ontdekking gekomen dat er bepaalde partijen verzonden zijn die over hun officiële vervaldatum waren.
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Mölnlycke Health Care AB, 2024-02(02), specific batches of the Detachable EndoRetrieval Pouch, which can be either a Single Packed device or included as a component in identified Mölnlycke® Procedure trays
The device is used to contain and extract specimens during laparoscopie surgery. The mechanism of the listed device operates in a ...
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NRT X-Ray A/S, PR20230929-02, Celex
The event made the Celex system move without being under control of the operator. This may put patients or operators at risk.
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Epic Systems Corporation, SLG 8588391, Regulated Decision Support Framework
In a system configured as described below, when the following workflow is performed, the system clears the Calculated Administer ...
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Intuitive Surgical, Inc., ISIFA2024-02-R, SureForm45/60, Cannula Seal, Arm Drape, Obturator
Tot onze spijt moeten wij u mededelen dat Intuitive zich ervan bewust is geworden dat bepaalde partijen van de volgende producten ...