Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.599 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Tandem Diabetes Care, Inc., FSN-FSCA-2022-02; MDD22.004, t:slim X2 Insulin Pump
Inputting incorrect values in your Personal Profile can lead to under-delivery or over-delivery of insulin, which could result in ...
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Malvern Medical Developments Ltd MC333 - S14 Oracol+ Saliva Collection Device
Er is door interne tests en tests van klanten aangetoond dat er tijdens het centrifugeerproces waarmee het monster uit het ...
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Bio-Rad_DiaMed GmbH FSCA 003-21 - ID-DiaCell I-II-III and ID-DiaCell IP-IIP-IIIP
Further to customer reports, we have been able to confirm that marked hemolysis can be observed with the ID-DiaCell I-II-III and ...
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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 ...