Sandhill Scientific, Inc 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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Sandhill Scientific, Inc
Lot Codes / Batch Numbers
S98-1925-2H, S98-1925-4H All lots and shipments of the software.
Products Sold
S98-1925-2H; S98-1925-4H All lots and shipments of the software.
Sandhill Scientific, Inc is recalling Insight rev H software. The InSIGHT Gastrointestinal Motility System is intended for use by gastro due to Software error may produce incorrect esophageal contraction readings.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software error may produce incorrect esophageal contraction readings.
Recommended Action
Per FDA guidance
Sandhill Scientific sent a Urgent Product Recall letter dated February 23, 2009, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were informed All Suite revision H, BioVIEW Analysis Software rev 5.5.1 are affected. Replacement of the Suite revision H, BioVIEW Analysis Software rev 5.5.1, will be provided at no cost to you. Sandhill Scientific will pay for shipping/handling charges associated with replacement of this software. We anticipate that by the first week of March, we will be able to provide you with the Software that resolves this problem. For further questions please call toll free 800-468-4556.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026