Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.589 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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SENTINEL CH. S.p.A., 03/2023; FA02OCT2023, IRON, IRON, Alinity c Iron Reagent
It has been identified that when using the ARCHITECT and Alinity c Iron products for the lots listed above, variable results can ...
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Siemens Shenzhen Magnetic Resonance Ltd., MR078/23/S, Headband of the over-ear headphones
This letter is to inform you about potential dot- or line-shaped artifacts caused by the presence of lubricating grease within ...
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Medtronic Navigation, Inc., FA1361, Neuroscience CST - StealthStation™ S8 App version 2.0 and 2.0.1
Medtronic heeft een softwareprobleem geïdentificeerd in de StealthStation™ S8-app, softwareversies 2.0 en 2.0.1 dat kan optreden ...
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lmmunotech S.A.S. - A Beckman Coulter Company, 23043, Access hsTnI Reagent
Beckman Coulter heeft vastgesteld dat er na de upgrade naar systeemsoftware 7.0.0 en hoger een restrisico op intratestoverdracht ...
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Medeco B.V., FSN2023-01, Klinion Kliniray (Abdominal) Gauze Compress X-Ray
After assessment of these products, it became known that x-ray threads in gauze compresses can disintegrate. It has been ...
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TRUMPF Medizin Systeme GmbH Co. KG, FA-2023-047
The potential impact for the missing IFU is that the users will not have awareness of appropriate use of the accessories, or ...
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Covidien llc, FA1370, McGrath MAC Video Laryngoscope
Medtronic is issuing this notification to inform the public of stolen defective McGRATH™ MAC video laryngoscopes that have been ...
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Seffiline S.R.L., SEFFIHAIR 3.1-SEFFICARE 3.1-SEFFIGYN 3.1-SEFFILLER 3.1 Seffiline S.r.l.
During the assembly of the kits, two transfers for luerlock syringes supplied by a supplier other than the one qualified by ...
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Atrium Medical Corporation, 3011175548-08.18.2023-001-C, Atrium Ocean Water Seal Chest Drains
The Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution ...
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Masimo Corporation, TC-I Reusable Tip Clip Sensor; MDSS ref: MDD23.148, TC-I Reusable Tip Clip Sensor
Masimo identified TC- I Reusable Tip Clip sensors with higher than expected variability in SpO2 readings that are outside of the ...