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.
FDA Recall Z-1487-2012 · Posted 2012-05-07
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Recalling FirmSandhill Scientific, Inc
Recall StatusTerminated
Product CodeFFX
Date Initiated2009-02-23
Date Terminated2012-05-07
Product Quantity60 programs
Reason for Recall
Software error may produce incorrect esophageal contraction readings.
Firm Action
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.
Root Cause
Software change control
Distribution Pattern
Worldwide Distribution--USA (nationwide) including the states of CA, CO, CT, FL, IA, IL, MA, MD, MI, MN, NC, ND, NE, NM, NY, OH, OR, PA, SC, SD, TX, UT, VA and WA and the countries of Belgium, Canada, Malaysia, Mexico, New Zealand, South-Korea, Switzerland and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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