Z-0974-2013Class II

INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual. Part #...

Name: Z-0974-2013 INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual. Part #...
Creator: Intio Inc
Published: 2013-02-26
License: https://open.fda.gov/license/

Intio Inc / initiated 2013-02-26 / Terminated / root cause: labeling and UDI

FDA source

Intio Inc began a recall of INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual. Part #: UM-06-20-0003. ClearStart-SVM is used for patient assessment... on 2013-02-26. FDA classified it as Class II and gives the reason as "INTIO Inc. distributed a SVM User's Manual and it has an editing mistake that could be interpreted as promoting an unapproved use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0974-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-26
Posted: 2013-03-20
Terminated: 2013-04-17
Recalling firm: Intio Inc
Product: INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual. Part #: UM-06-20-0003. ClearStart-SVM is used for patient assessment using CT (computed tomography) images, in order to plan potential therapies or monitor tumor response to treatment.
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: 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 [email protected] or call 303-396-1777. For questions regarding this recall call 303-396-9291.
Quantity in commerce: 7
Distribution: Nationwide Distribution including MN, FL, PA, WI, NY, and RI.
Product codes and lots: INTIO Inc. Part #: UM-06-20-0003 for SVM User's Manual

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0974-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0974-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-27	2013-03-20

Product code LLZ

K113541Class IIClearstart Svm SystemIntio, Inc. / cleared 2011-12-16

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)