FDAClass IIMarch 27, 2013

Intio Inc recall

INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual. Part #: UM-06-20-0003. ClearStart-SVM is used for patient…

Why was Intio Inc recalled?

INTIO Inc. distributed a SVM User's Manual and it has an editing mistake that could be interpreted as promoting an unapproved use.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual. Part #: UM-06-20-0003. ClearStart-SVM is used for patient…
Recalling firm
Intio Inc
Quantity
7
Distribution
Nationwide Distribution including MN, FL, PA, WI, NY, and RI.
Recall date
March 27, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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