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FDA Medical Device Recalls (openFDA)

Baxter Healthcare Corp.: Clinician Workstation Software, product code 2M5042

Recall number
Z-0981-05
Recalling firm
Baxter Healthcare Corp.
Product
Clinician Workstation Software, product code 2M5042
Status
Terminated
Initiated
2005-03-10
Posted
2005-07-13
Terminated
2008-02-06
Reason
The medication administration results displayed in the 'View Results' link may be inaccurate.
Root cause
Other
Action
Urgent Device Correction recall letters dated 3/10/05 were sent to the direct accounts on the same date via first class mail. The letter describes the inaccuracies in the 'View Results' program, and informed the accounts that inaccurate information could lead to incorrect clinical decision-making, which could impact a patient''s medication treatment protocol. The accounts were requested to disable the 'View Results' link until a software upgrade is available, and to inform all clinical point of care users that the 'View Results' has been disabled and that the Manual Adminstration Record is to be used as the primary source of information for reviewing medication adminstration results. The accounts were instructed to contact their account executive and/or the Client Support Services at 1-877-835-2727 for instructions on how to disable the 'View Results' feature.
Quantity
5 units
Distribution
Missouri, Massachusetts, Vermont, California and Canada.
Lot, serial or model codes
Product code 2M5042, software versions 3.4, 4.0 and 4.1
510(k) numbers
not on file
PMA numbers
not on file
Product code
LNX
Firm FEI
1416980
Firm city
Round Lake
Firm state
IL
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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