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Insight rev H software recallZ-1487-2012 · Sandhill Scientific, Inc · initiated Feb 23, 2009

Terminated All recalls posted in May 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Sandhill Scientific, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Software error may produce incorrect esophageal contraction readings.

FDA root cause category: Software change control

What the company is doing

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.

Recall details

Recall number
Z-1487-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Feb 23, 2009
Posted by the FDA
May 7, 2012
Recalling firm
Sandhill Scientific, Inc
Quantity
60 programs
Product code
FFX
FDA submissions
K012232
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.

Product description

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 (models, lots, serial numbers)

S98-1925-2H; S98-1925-4H All lots and shipments of the software.

Other devices under the same FDA submission

3 devices cleared under K012232 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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