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FDA Medical Device Recalls (openFDA)

Sunquest Information Systems: Reference Library Interface Version 5.3

Recall number
Z-0497-03
Recalling firm
Sunquest Information Systems
Product
Reference Library Interface Version 5.3
Status
Terminated
Initiated
2002-12-06
Posted
2003-01-30
Terminated
2013-02-26
Reason
Software system defect resulting in incomplete patient results information.
Root cause
Other
Action
Product Safety Notice, PSN-02-L31 will be faxed to all affected customers. The notice provides product users with a description of the problem, an effective workaround, and the estimated release of coding modifications to the software version impacted.
Quantity
30
Distribution
Nationwide
Lot, serial or model codes
Version 5.3
510(k) numbers
not on file
PMA numbers
not on file
Product code
JQP
Firm FEI
1000306472
Firm city
Tucson
Firm state
AZ
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

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