Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.325 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Mevion Medical Systems, FSN-FSCA_220209, Mevion S250i
Mevion was informed of an instance where a user changed only the Setup isocenter in ARIA in a previously approved plan, without ...
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Thermo Fisher Scientific, FSN-2022-001, Remel Culti-Loops E. floccosum ATCC 52066 PK/5
An internal technical investigation has confirmed that Remel™ Culti-Loops™ E. floccosum ATCC™ 52066™ PK/5 R4601977 Lot 255302 may ...
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Instrumentation Laboratory, 2022_001, HemosIL AcuStar ADAMTS13
We hebben klachten van klanten ontvangen over resultaten van patiëntmonsters onder de normaal grens van <10% activiteit met de ...
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Illumina, QI-000509, NextSeq 550Dx
Illumina heeft een probleem vastgesteld dat kortsluiting kan veroorzaken in de behuizing van het instrument.
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Baxter, FA-2022-006, PrisMax V2 ROW- V3 ROW
Baxter Healthcare Corporation is issuing a Device Correction to the user level for the PrisMax System. This correction is due to ...
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RaySearch Laboratories, RayCare
This notice concerns an issue found with the report database in RayCare 5A and 5B including some servicepacks.
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Hillrom, FA-2021-12-003-BAT-008, Compella Bariatric Bed and Controller
Tijdens de levensduur van het Compella bed en de Compella luchttoevoerunit kan het netsnoer beschadigd raken als gevolg van ...
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Siemens Healthcare Diagnostics AIMC 22-03 - Atellica® Solution and ADVIA Centaur® Systems
Siemens Healthcare Diagnostics Inc. has confirmed customer observations of falsely elevated results when using plasma specimens ...
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Getinge Disinfection CAPA 555530 - Getinge 9100-series - Washer Disinfector
Getinge has discovered that verification of installation is not always documented or the documentation is incomplete and does not ...
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Siemens Healthcare Diagnostics POC 22-002 - Atellica® UAS 800 Urine Sediment Analyzer & Atellica® 1500 Automated Urinalysis System
Siemens Healthcare Diagnostics has confirmed that the door gas spring which holds the analyzer door open is failing before its ...