Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.594 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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MAQUET GmbH, 2023-02, MEERA operating table with autodrive
Under certain conditions, we have identified that an issue might prevent the device from performing as intended. A specific ...
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GE Healthcare Finland Oy, FMI 36159, Portrait Wearable Pulse Oximetry Sensors
Bepaald PortraitTM draagbare pulsoximetrie Sensoren P-SE01 en P-W01, kunnen, als ze verzadigd zijn met vloeistoffen, leiden tot ...
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Diagnostic Grifols S.A., 800012097, ERYTRA EFLEXIS
The analyzer may give incorrect interpretations of a profile that includes multiple techniques under certain conditions.
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Philips Medical Systems DMC GmbH, 2023-PD-DXR-009, Essenta DR Compact
There is a potential cybersecurity issue with Essenta DR Compact Systems, which could result in unauthorized disclosure or ...
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B.Braun Melsungen AG, FSCA-2023-08-14 (2), Spaceplus Infusomat
Tijdens de Post Market Surveillance-activiteiten hebben we een sporadisch voorkomen van mogelijk valse down- en upstream ...
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Covidien IIc, FA1355, Palindrome Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8 mm) x 23 cm
Bij analyse na het in de handel brengen werd vastgesteld dat bij sommige kathetersets in vier (4) specifieke loten van de ...
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Invivoscribe, Inc., 3014173060-07-18-23-003-C, LymphoTrackDx IGH - MiSeq
The impacted master mix lots, when used to amplify clinical samples, will not produce amplification of the VH7 region. In the ...
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Siemens Healthcare Diagnostics Inc., CHC 23-02, ADVIA Chemistry Iron_2 (IRON_2) Reagents
Siemens Healthcare Diagnostics Inc. has confirmed, through investigation of customer complaints, the potential for a positive ...
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B.Braun Melsungen AG, FSCA-2023-08-14(1), INFUSOMAT SPACE
Tijdens de Post Market Surveillance-activiteiten hebben we een sporadisch voorkomen van mogelijk valse down- en upstream ...
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Medima Sp. z o. o., FSCA-2023-01, Volumetric infusion pump & infusion sets
Issue 1: Potential for reverse installation of infusion sets intoMedima Volumetric infusion pumps. Issue 2: Potential for a ...