Insight rev H software. The InSIGHT Gastrointestinal Motility System is intended for use by gastroenterologists, surgeon
FDA device recall Z-1487-2012 · posted 2012-05-07 · Terminated
Recall details
- Recalling firm
- Sandhill Scientific, Inc
- Reason for recall
- Software error may produce incorrect esophageal contraction readings.
- Action taken
- 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.
- Root cause
- Software change control
- Status
- Terminated
- Product code
- FFX
- Quantity affected
- 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,
- Date initiated
- 2009-02-23
- Date posted
- 2012-05-07
- Date terminated
- 2012-05-07
- Location
- Highlands Ranch, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INSIGHT, MODEL S980000 (K012232) | Sandhill Scientific, Inc. | 2002-06-07 |