Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.325 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Philips Goldway (Shenzhen) Industrial Inc., FSN-FSCA 2021-CC-EC-019-IR, Philips HeartStart Intrepid Monitor/Defibrillator
The HeartStart Intrepid 12-Lead ECG feature may lose the ECG signal when (a) it is connected to the patient and (b) the Right Leg ...
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Advanced Medical Solutions Ltd, FSN-01-31-2022-001-FSCA, LiquiBandFIX8® Open Hernia Mesh Fixation Device
AMS has become aware of a mechanical device defect in the Product during an internal testing of device. The defect causes ...
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Maquet Critical Care FSCA-MCC_22_001 - Servo-u and Servo-n ventilator systems
For ventilators operating at mains power voltage 220V-240V, we have identified that a current-limiting resistor on the AC/DC ...
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Medtronic FA1216 - MiniMed™ 600 and 700 series insulin pump
Serious injuries have been reported with the use of the MiniMed™ 600 series and MiniMed™ 700 series insulin pumps which may be ...
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Pulsion Medical Systems FA574697 - PiCCO Monitoring Kit + ProAQT Sensor
We have identified that the listed products have been produced with packaging material that is suspected to have an uncoated ...
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B.Braun Medical FSCA 2022-02-07 STK/AS - Infusomat® Space Line (transfusie)
Gedurende onze post-market surveillanceactiviteiten is vastgesteld dat de lijmverbinding tussen de slang en de patiëntconnector ...
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Philips Medical Systems FSN-2021-CC-HPM-074 - Esophageal_Rectal_Skin Temperature Probes
The Esophageal/Rectal/Skin Temperature Probe’s Instructions for Use, (IFU), contain inadequate instructions related to the ...
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BIP Biomedizinische Instrumente und Produkte CN-104 - BIP O-Twist-Marker SRX
In the course of performing dye penetration tests in accordance with ASTM F1929-15 on currently used sterile peel pouches of the ...
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BSN Medical GmbH, FSN-QIM 500077717 / 500077719, Jobst Compri2 / Jobst Compri2 Lite
We zijn geïnformeerd dat de etikettering van de hierboven vermelde partij misleidend kan zijn. De omdozen van de betrokken partij ...
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Össur hf, FSN-032021, RESOLVE HALO
Er is vastgesteld dat de high impact polystyreen trays van Resolve® Halo Rings en Össur Halo Rings kunnen barsten of prikken ...