Recall Z-1487-2012
Sandhill Scientific, Inc · initiated February 23, 2009
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.
Codes / lots: S98-1925-2H; S98-1925-4H All lots and shipments of the software.
Reason for recall
Software error may produce incorrect esophageal contraction readings.
FDA-determined cause: Software change control
Action taken
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.
Details
- Recall number
- Z-1487-2012
- Initiated
- February 23, 2009
- Posted by FDA
- May 7, 2012
- Terminated
- May 7, 2012
- Product code
- FFX – System, Gastrointestinal Motility (Electrical)
- Quantity
- 60 programs
- Distribution
- 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.
- Recalling firm
- Sandhill Scientific, Inc, Highlands Ranch, CO