Recall Z-0919-2014 ยท LLZ System, Image Processing, Radiological
AGFA Corp.
IMPAX RIS QDOC 5.8
| Date | Feb 3, 2014 (initiated Jan 8, 2014) |
| Status | Terminated |
| Reason | Patient name displayed (printed) on the Patient Report was the wrong patient name. |
| Root cause | Unknown/Undetermined by firm |
| Action | 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. |
| Quantity | 14 |
| Distribution | CA, FL, GA, ME, OH, OR, SC, SD, TX and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111945 | IMPAX NEXT GENERATION Agfa Healthcare N.V., Aug 5, 2011 |