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U.S. Department of Health and Human Services

Class 2 Device Recall Logix Order Entry (OE) Software

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  Class 2 Device Recall Logix Order Entry (OE) Software see related information
Date Initiated by Firm March 29, 2011
Date Posted May 25, 2011
Recall Status1 Terminated 3 on January 05, 2017
Recall Number Z-2291-2011
Recall Event ID 58420
Product Classification System/device, pharmacy compounding - set, i.v. fluid transfer - Product Code LHI
Product LOGIX Order Entry (OE) Software, all versions, catalog 2M8410; Baxter Healthcare, Deerfield, IL 60015;

The software is included in a number of Baxter's pharmacy compounders. The software assists the pharmacist in management of compounding, creating and authorizing nutritional solutions intended for IV administration.
Code Information catalog 2M8410, all software versions
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 LOGIX OE automated backup does not retain the three most recent backup files and instead will only retain the last three backups of the previous year. The software stores backup files in numeric order rather than chronological date order.
FDA Determined
Cause 2		 Software design
Action Baxter Healthcare Corp. sent an URGENT DEVICE CORRECTION letter dated March 29, 2011, via first class mail to all affected customers. The letter identified the product, the problem and the action to be taken by the customer. It was discovered there is an issue with the LOGIX OE automated backup not retaining the three most recent backup files and instead will only retain the last three backups of the previous year. The accounts were requested to turn off the automated backup function on the LOGIX OE Software, and perform manual backups following the instructions included in the Urgent Device Correction letter, and retain a copy of the letter at each computer on which LOGIX OE Server is installed. The customer were also requested to complete the attached customer reply form and fax it to Baxter at the number provided on the form. Any questions regarding the communication were directed to Baxter's Medical Information Services at 1-800-422-2751.
Quantity in Commerce 84 units
Distribution Worldwide Distribution -- USA including Puerto Rico, and the country 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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