The Food and Drug Administration has recalled 15 Philips Medical Systems Tomoscan SR4000 CT scanners because of a defect that shows up when an image is reversed in the system’s databank, according to an FDA enforcement report. The defect in the
The Food and Drug Administration has recalled 15 Philips Medical Systems Tomoscan SR4000 CT scanners because of a defect that shows up when an image is reversed in the systems databank, according to an FDA enforcement report. The defect in the system causes a patients image to be reversed left to right when a clinician retrieves it.
The problem was found during a routine FDA inspection several months ago, a Philips official said. He said the company hasnt received any complaints from customers.
There has to be a very specific set of circumstances for (the defect) to happen, the Philips official said. We have identified it as possible, and we are taking steps to correct the information.
