donderdag 14 februari 2019

IGJ waarschuwingen: Bausch & Lomb CAC-2018-014 - Stellaris Elite Single Port Vitrectomy Cutters

Bausch & Lomb CAC-2018-014 - Stellaris Elite Single Port Vitrectomy Cutters
We are initiating this recall after having received a limited number of customer reports of the back cap separating from the body of the cutter during surgery.
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Accuray CKFA19-004 - CyberKnife® Treatment Delivery System
The Ball-Cube II phantom calibration film (Ball-Cube II film) was not manufactured within necessary dimensions and may introduce up to 0.5 mm of positional inaccuracy to the CyberKnife® System.
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Siemens AX059_17_S - Artis zee ceiling systems
During regular product monitoring abrasion was identified at the cabling at some systems. In detail, abrasion may occur in the area of the cable outlet at the interior C-arm.
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NTOC_DePuy Synthes 1296193 - Locking Module for the Variable Angle (VA) Locking Hand System
De siliconenstrip in de 68.130.109 *, instrumentlade kan buiten de specificaties vallen. De betreffende module kan een gele siliconenstrip bevatten met negen (9) uitgesneden gaten in plaats van de vereiste gele siliconenstrip met tien (10) uitsparingen.
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Biomet Orthopaedics, ZFA 2017-298 , Antegrade Femoral Connecting Bolt
Zimmer Biomet is conducting a medical device Field Safety Corrective Action (removal) for specific production. Lots of the Antegrade Femoral Connecting Bolt. Zimmer Biomet has received reports of connecting boltfractures during insertion of the femoral nail. The scope of this removal is isolated to product manufactured between 2008 and 2010. If the bolt were to fracture during use, which would be...
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