Z-1487-2012

Insight rev H software. The InSIGHT Gastrointestinal Motility System is intended for use by...

Name: Z-1487-2012 Insight rev H software. The InSIGHT Gastrointestinal Motility System is intended for use by...
Creator: Sandhill Scientific, Inc
Published: 2009-02-23
License: https://open.fda.gov/license/

Diversatek Healthcare Inc / initiated 2009-02-23 / Terminated / root cause: software

FDA source

Sandhill Scientific, Inc began a recall of Insight rev H software. The InSIGHT Gastrointestinal Motility System is intended for use by gastroenterologists, surgeons, and medically trained personnel for... on 2009-02-23. The reason FDA records is "Software error may produce incorrect esophageal contraction readings". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1487-2012
Status: Terminated
Initiated: 2009-02-23
Posted: 2012-05-07
Terminated: 2012-05-07
Recalling firm: Diversatek Healthcare Inc
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.
Product code: FFX System, Gastrointestinal Motility (Electrical)
Reason for recall: Software error may produce incorrect esophageal contraction readings.
Root cause tag: software
FDA root cause: 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.
Product codes and lots: S98-1925-2H; S98-1925-4H All lots and shipments of the software.

Product code FFX

K012232Class IIInsight, Model S980000Sandhill Scientific, Inc. / cleared 2002-06-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)