Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2291-2011

LOGIX Order Entry (OE) Software, all versions, catalog 2M8410; Baxter Healthcare, Deerfield, IL 60015; The...

Baxter Healthcare Corporation / initiated 2011-03-29 / Terminated / root cause: software

Baxter Healthcare Corp. began a recall of LOGIX Order Entry (OE) Software, all versions, catalog 2M8410; Baxter Healthcare, Deerfield, IL 60015; The software is included in a number of Baxter's... on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-2291-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Baxter Healthcare Corporation
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.
Product code
LHI Set, I.V. Fluid Transfer
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.
Root cause tag
software
FDA root cause
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.
Product codes and lots
catalog 2M8410, all software versions