INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual. Part #: UM-06-20-0003. ClearSta
FDA device recall Z-0974-2013 · posted 2013-03-20 · Terminated
Recall details
- Recalling firm
- Intio Inc
- Reason for recall
- INTIO Inc. distributed a SVM User's Manual and it has an editing mistake that could be interpreted as promoting an unapproved use.
- Action taken
- INTIO sent a Recall Notice to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. INTIO has corrected this version of the SVM User's Manual. An INTIO Inc. employee will contact the customers to replace the current manual with the correct one. Consignees were notified by letter that an INTIO Inc. employee will contact you within the next 30 days to replace the current manual with the correct one. The new SVM User's Manual will be provided to you once INTIO Inc. has retrieved the incorrect version of the SVM User's Manual. Customers with questions were instructed to email support@intio.us or call 303-396-1777. For questions regarding this recall call 303-396-9291.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 7
- Distribution
- Nationwide Distribution including MN, FL, PA, WI, NY, and RI.
- Date initiated
- 2013-02-26
- Date posted
- 2013-03-20
- Date terminated
- 2013-04-17
- Location
- Broomfield, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CLEARSTART SVM SYSTEM (K113541) | Intio, Inc. | 2011-12-16 |