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FDA Medical Device Recalls (openFDA)

SCC Soft Computer: Product is SoftPath ASCII Software Releases 2.3.0 and 4.3.7. The software is used in pathology labs for administrative and clinicial documentation and data processing.

Recall number
Z-1243-06
Recalling firm
SCC Soft Computer
Product
Product is SoftPath ASCII Software Releases 2.3.0 and 4.3.7. The software is used in pathology labs for administrative and clinicial documentation and data processing.
Status
Terminated
Initiated
2004-10-27
Posted
2006-07-27
Terminated
2010-07-19
Reason
Text from one case is overwriting another. This could cause an incorrect diagnostic report to be sent to a clinician/surgeon.
Root cause
Other
Action
Consignees were notified and the products were corrected by the firm.
Quantity
4
Distribution
Product was distributed to 4 clients, two in the United States and two in Canada.
Lot, serial or model codes
Releases 2.3.0 and 4.3.7.
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

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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

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