Intio ClearStart-SVM User Manual Recalled for Editing Mistake
Intio Inc. is recalling seven copies of the ClearStart-SVM User Manual due to an editing mistake that could be interpreted as promoting an unapproved use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a documentation issue (editing mistake in a user manual) with no reported injuries or illnesses, fitting the 'Low' severity criteria for documentation issues.
Plain-English summary
Intio Inc. is recalling seven copies of the ClearStart-SVM Segmentation and Volumetric Measurement System User Manual, Part #: UM-06-20-0003. The recall is due to an editing mistake in the manual that could be interpreted as promoting an unapproved use of the software.
The ClearStart-SVM system is used for patient assessment using CT (computed tomography) images to plan potential therapies or monitor tumor response to treatment. The affected manuals were distributed nationwide, including to locations in Minnesota, Florida, Pennsylvania, Wisconsin, New York, and Rhode Island.
Consumers and healthcare providers who possess this specific manual should stop using it and contact Intio Inc. for instructions on how to return the document or obtain a corrected version.
The recalled product
- 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.
- Manufacturer
- Intio Inc
- Hazard
- Affected units
- 7
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- INTIO Inc. Part #: UM-06-20-0003 for SVM User's Manual
Distribution
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