FDA Medical Device Recalls (openFDA)
SCC Soft Computer: SoftPath ASCII Software, used in pathology labs to track and report specimens and diagnostic results. Releases 1.2, 2.1, and 2.3
- Recall number
- Z-1252-06
- Recalling firm
- SCC Soft Computer
- Product
- SoftPath ASCII Software, used in pathology labs to track and report specimens and diagnostic results. Releases 1.2, 2.1, and 2.3
- Status
- Terminated
- Initiated
- 2001-01-09
- Posted
- 2006-07-26
- Terminated
- 2010-07-19
- Reason
- The client had made a decision to use the SoftPath Module in a nonstandard manner. Under specific circumstances, incorrect text may appear on a patient report.
- Root cause
- Other
- Action
- The firm issued a software correction letter to its consignees 1/9/2001, advising them of the problem and supplied them with a software patch ICC number 3618 also referred to as release 3.0. The firm advised its clients that the installation of this software to their system was mandatory.
- Quantity
- 171
- Distribution
- Nationwide and Canada.
- Lot, serial or model codes
- Releases 1.2, 2.1, and 2.3
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- Firm FEI
- 1000307651
- Firm city
- Palm Harbor
- Firm state
- FL
- 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