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FDA Medical Device Recalls (openFDA)

Misys Healthcare Systems: Misys Laboratory System version 5.3

Recall number
Z-0807-03
Recalling firm
Misys Healthcare Systems
Product
Misys Laboratory System version 5.3
Status
Terminated
Initiated
2003-04-01
Posted
2003-05-09
Terminated
2004-04-21
Reason
Software anomally, One client reported patient tests and results are deleted when duplicate orders are placed.
Root cause
Other
Action
Notice was sent by fax on 4/1/2003 under Product Safety Notice, PSN-03-L17. A code modification is yet to be released. Customers have been provided with a temporary workaround procedure.
Quantity
3
Distribution
States of MI, OH, NY.
Lot, serial or model codes
Version 5.3 only.
510(k) numbers
not on file
PMA numbers
not on file
Product code
not on file
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

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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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