Device product
IMPAX RIS QDOC 5.8
Z-0919-2014
Product summary
- Firm
- AGFA Corp.
- Event
- Event 67275
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14
- Official record key
device-enforcement:Z-0919-2014
Official wording
Reason: Patient name displayed (printed) on the Patient Report was the wrong patient name.
Code information: Software IMPAX RIS 58 and higher
Distribution pattern: CA, FL, GA, ME, OH, OR, SC, SD, TX and Canada
Derived failure modes
-
Unknown
Patient name displayed (printed) on the Patient Report was the wrong patient name.