Company:superDimension, Inc
Date of Enforcement Report 7/18/12
Class ll:
PRODUCT
superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use. Z-2001-2012
REASON
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, and then generates an error message.
RECALLING FIRM/MANUFACTURER
superDimension, Inc, Minneapolis, MN on 6/18/2012. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
99 units
DISTRIBUTION
Nationwide and Internationally
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