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U.S. Department of Health and Human Services

Class 2 Device Recall Insight

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  Class 2 Device Recall Insight see related information
Date Initiated by Firm February 23, 2009
Date Posted May 07, 2012
Recall Status1 Terminated 3 on May 07, 2012
Recall Number Z-1487-2012
Recall Event ID 53340
510(K)Number K012232  
Product Classification System, gastrointestinal motility (electrical) - Product Code FFX
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.
Code Information S98-1925-2H; S98-1925-4H All lots and shipments of the software.
Recalling Firm/
Manufacturer		 Sandhill Scientific, Inc
9150 Commerce Center Cir Ste 500
Highlands Ranch CO 80129-1563
For Additional Information Contact Guy Harris
800-468-4556 Ext. 1021
Manufacturer Reason
for Recall		 Software error may produce incorrect esophageal contraction readings.
FDA Determined
Cause 2		 Software change control
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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FFX and Original Applicant = SANDHILL SCIENTIFIC, INC.
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