Intio Inc: Medical Device Recall in 2013 - (Recall #: Z-0974-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: February 26, 2013

Date Posted: March 27, 2013

Recall Number: Z-0974-2013

Event ID: 64435

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.

Status: Terminated

Product Quantity: 7

Code Information:

INTIO Inc. Part #: UM-06-20-0003 for SVM User's Manual

Distribution Pattern:

Nationwide Distribution including MN, FL, PA, WI, NY, and RI.

Voluntary or Mandated:

Voluntary: Firm initiated