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Focal Software: When a patient is defined as prone and the shifts are manually entered and the LOCK SHIFT box is checked the X coordinate (left/right) and the Z coordinate (anterior/posterior) are reversed (left to right, anterior to posterior). This could potentially lead to incorrect isocenter definitions from prone patients and thus a mislocation of dose.
ev3 Inc. is conducting a voluntary recall of specific lots of the Protege GPS Self-Expanding Stent System because labeling did not match the actual stent size contained in the package. The affected product was labeled as a 6mm x 80mm Protege GPS stent but actually contained an 8mm x 40mm stent. This situation can lead to vessel damage or inadequate coverage of the target lesion.