FDA Medical Device Recalls (openFDA)
iCAD, Inc.: CAD SCIENCES LLC 3TP PrecisionPointTM Software, for biopsy guidance.
- Recall number
- Z-0654-2009
- Recalling firm
- iCAD, Inc.
- Product
- CAD SCIENCES LLC 3TP PrecisionPointTM Software, for biopsy guidance.
- Status
- Terminated
- Initiated
- 2008-12-09
- Posted
- 2009-01-27
- Terminated
- 2016-01-28
- Reason
- Software modules not approved for this indication.
- Root cause
- PMA
- Action
- iCAD initiated a voluntary field correction by telephone and letter on 12/5/08 by disabling these features at all affected sites. Since Precision Point and TheraMap are controlled by a software license key, iCAD will disable these features by updating the license at the affected sites.
- Quantity
- 35
- Distribution
- Nationwide distribution to: CA, FL, HI, KS, NH, NJ. NY, MA, MO, MI ,NC, OH, SC, and WI.
- Lot, serial or model codes
- All software versions
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 3026970882
- Firm city
- Nashua
- Firm state
- NH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28