FDA Device recall Z-0919-2014
IMPAX RIS QDOC 5.8
- FDA Device
- Class II
- terminated
- Published 2014-02-12
On 2014-02-12 the FDA classified a Class II recall of IMPAX RIS QDOC 5.8 by Agfa, citing patient name displayed (printed) on the Patient Report was the wrong patient name.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0919-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-01-08 |
| Published | 2014-02-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Agfa |
| Distribution | CA, FL, GA, ME, OH, OR, SC, SD, TX |
Product
IMPAX RIS QDOC 5.8
Reason
Patient name displayed (printed) on the Patient Report was the wrong patient name.
Identifiers
| code_info | Software IMPAX RIS 58 and higher |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0919-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.