IMPAX RIS QDOC 5.8
- Company
- Agfa Corp.
- Recall Initiated
- January 8, 2014
- Posted
- February 3, 2014
- Terminated
- February 28, 2014
- Recall Number
- Z-0919-2014
- Quantity
- 14
- Firm Location
- Greenville, SC
Reason for Recall
Patient name displayed (printed) on the Patient Report was the wrong patient name.
Distribution
CA, FL, GA, ME, OH, OR, SC, SD, TX and Canada
Lot / Code Info
Software IMPAX RIS 58 and higher
Root Cause
Unknown/Undetermined by firm
Action Taken
On January 8, 2014, an "URGENT FIELD SAFETY NOTICE" (UFSN) letter was emailed to consignees. The letter described the safety alert and mitigation, including directions to consignees as to how the disable Microsoft Word Background Printing. Acknowledgment via FAX-Back or email, that the information was received and understood was requested from the consignees.
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