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vrijdag 7 december 2018

IGJ waarschuwingen: VascoMed GmbH, VM-2018-12, TC-115 Balloon

VascoMed GmbH, VM-2018-12, TC-115 Balloon
Reason for this field safety action is a potentially incorrect labeling of the outer boxes of the product "TC-ll5-Ballon".
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ArjoHuntleigh, FSN-POZ-004-2018, Minstrel
This letter is to inform you of a corrective action that will be performed to prevent risk of the spreader bar detachment from the lifting arm during patient transfer.
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Getinge Lancer SAS, CAPA227500, Fibrocleaner
Uit meldingen van klanten is naar voren gekomen dat het gebruik van Fibrocleaner kan leiden tot rookontwikkeling, oververhitting of zelfs ontbranding van het apparaat.
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RaySearch Laboratories FSN37483 - RayStation 3.5, 4.0, 4.5, 4.7, 5, 6, 7, 8A
This notice concerns an issue found with isocenter shifts when using dose tracking in RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A. In these versions, isocenter shifts in dose tracking are incorrectly interpreted according to the DICOM patient coordinate system.
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Waldemar Link FSN R-2018-02 - BiMobile UHMWPE Liner
lt has been noticed that the patient labels of article 184-260/04 (Outer 0 54mm) Lot 1707116 and article 184-260/02 (Outer 0 50 mm) Lot 1707121 could have been mismatched.
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