Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.586 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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IMMY, 1627497-2019-00002; IVD19.054, sona Aspergillus GM Lateral Flow Assay
As part of post-market surveillance activities, the above device was found to cause weak false-positive results.
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Emerging Implant Technologies GmbH (EIT) 1619673-FA - EIT Implants (Cervical, PLIF, TLIF)
Deze vrijwillige veiligheidsmelding wordt uitgegeven omdat het etiket van de binnenblister en het etiket van de buitenverpakking ...
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Becton Dickinson GmbH BDDS-19-1857 BD CHROMagar™ Orientation Medium
BD has recently become aware through customer feedback of bacterial contamination on the above listed lots of non-sterile ...
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IMTMEDICAL AG, 2019-001, bellavista 1000 XX, bellavista 950
Bij hardware van de generaties G2/3/4/5/6 van de bellavista-beademingsapparaten uit de series 1000 en 950 kunnen tijdens de ...
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Radiometer Medical, FAN 915-402, AQT90 FLEX analyzer
Radiometer has become aware that certain Lots of Cleaning Solution tubes for the AQT90 FLEX has been produced with an incorrect ...
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Covidien, Event-2019-02412, Genius Tympanic Thermometer
The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that ...
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bioMérieux, FCA 4532, BACT_ALERT VIRTUO
Baxter Healthcare Corporation is issuing a voluntary product recall for the ArtiSet Blood Tubing Sets listed below due to the ...
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Align Technology, CMD-67847, Invisalign System
As a result of the software release on June 1, 2019, in some instances, customers were able to modify and re-approve a number of ...
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IMTMEDICAL AG 2019_002 bellavista 1000, 1000 NEO, 1000e 17.3 & 1000 set
Bij hardware van de generatie G6 van bellavista-beademingsapparatenuit de serie 1000 met bovengenoemde serienummers kan zich een ...
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bioMérieux SA, FSCA 4553, Cetrimide Agar
Based on the investigation results, there is a potential risk for False negative results for Pseudomonas aeruginosa with lot. # ...