Company: Sandhill Scientific, Inc.
Date of Enforcement Report 5/23/12
Class ll:
PRODUCT
Insight rev H software. The InSIGHT Gastrointestinal Motility System is intended for use by gastroenterologists, surgeons, and medically trained personnel for esophageal, biliary, and anorectal studies as an aid in documenting and diagnosing digestive motility disorders. Recall # Z-1487-2012
REASON
Software error may produce incorrect esophageal contraction readings.
RECALLING FIRM/MANUFACTURER
Sandhill Scientific, Inc. Highlands Ranch, CO, by letter dated February 23, 2009. Firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
60 units
DISTRIBUTION
Nationwide and Internationally
___________________________________