July 18, 2012Medical DevicesFDA
superDimension, Inc recalls superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the trac
Hazard: superDimension, Inc., is conducting a recall of certain superDimension Systems operating Software Version 4.0 - 4.9. The affected systems are sold under the product code AAS00016-xx. The products being recalled have been found to malfunction when connected to the superDimension Locatable Guide (LG). Specifically, the Systems using Software Version 4.0-4.9 will not recognize the Locatable Guide