Cl ll superDimension Systems AAS00016-xx

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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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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