Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.586 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Edwards Lifesciences LLC, FCA 127, Vamp Optima
The instructions for use are unclear in the steps for blood sampling and the positioning of the stopcock.
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Roche Diagnostics, CN-412018, BILD2 (Bilirubin direct Gen.2)
A low control recovery of BILD2 was observed immediately after cassette opening, with subsequent calibration of the affected ...
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A.R.C. Laser GmbH FSCA 29.03.2019 - surgical laser device Wolf (445 nm)
A software bug was detected by using the bar (pic01) to adjust the laser power of the device. That bug occur only in case four ...
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Abbott, FA29MAR2019, Alinity hq Analyzer
There is a potential for delay in the generation of patient results due to the increase in step loss on axis errors and seizing ...
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Ohmeda Medical, FMI 32067, Giraffe Bedded Warmers, Panda iRes Warmers
GE Healthcare has become aware that the bedside panels, and latch areas on the warmer can crack or break if the unit is moved ...
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R82 A/S, PMS 2019 03 NL WL FSCA, Wombat Living
When a session is opened in SureTyper v 6.0.0 for the first time, the software is not detecting the instrument that the raw data ...
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Thommen Medical FSCA 19_01 - Adapter for handpiece, guided reusable
Thommen Medical AG has found parts in a production batch of the above-mentioned medical device whose hardness does not conform to ...
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ViewRay Inc. 3011233554-03-18-2019-002-C - MRIdian Linac System
Onlangs is ViewRay door onze klanten van een probleem op de hoogte gebracht. Het probleem bestaat erin dat een fout in de ...
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Zimmer Biomet ZFA 2018-00611 - Foot and Ankle Instruments
Zimmer Biomet received a certain number of complaints reporting tip breakages. An investigation identifies that Normed Medizin ...
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Nobel Biocare, PFA1906, drills etc
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the ...