FDA Medical Device Recalls (openFDA)
Sandhill Scientific, Inc: 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.
- Recall number
- Z-1487-2012
- Recalling firm
- Sandhill Scientific, 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.
- Status
- Terminated
- Initiated
- 2009-02-23
- Posted
- 2012-05-07
- Terminated
- 2012-05-07
- Reason
- Software error may produce incorrect esophageal contraction readings.
- 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
- 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.
- Lot, serial or model codes
- S98-1925-2H; S98-1925-4H All lots and shipments of the software.
- 510(k) numbers
- ["K012232"]
- PMA numbers
- not on file
- Product code
- FFX
- Firm FEI
- 2023374
- Firm city
- Highlands Ranch
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28