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U.S. Department of Health and Human Services

Class 2 Device Recall Clinician Workstation

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  Class 2 Device Recall Clinician Workstation see related information
Date Initiated by Firm March 10, 2005
Date Posted July 13, 2005
Recall Status1 Terminated 3 on February 06, 2008
Recall Number Z-0981-05
Recall Event ID 31467
Product Classification Medical Computers And Software - Product Code LNX
Product Clinician Workstation Software, product code 2M5042
Code Information Product code 2M5042, software versions 3.4, 4.0 and 4.1
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
Rt. 120 & Wilson Rd
Round Lake IL 60073
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 The medication administration results displayed in the 'View Results' link may be inaccurate.
FDA Determined
Cause 2		 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 in Commerce 5 units
Distribution Missouri, Massachusetts, Vermont, California and Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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