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Class 2 Device Recall Insight |
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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
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Product Classification |
System, gastrointestinal motility (electrical) - Product Code FFX
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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
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For Additional Information Contact |
Guy Harris 800-468-4556 Ext. 1021
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Manufacturer Reason for Recall |
Software error may produce incorrect esophageal contraction readings.
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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
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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.
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510(K) Database |
510(K)s with Product Code = FFX and Original Applicant = SANDHILL SCIENTIFIC, INC.
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