IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of
FDA device recall Z-2069-2012 · posted 2012-07-24 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- When users selected "Left stenosis" in the "Graft Duplex Conclusion" section in IMPAX CV Reporting Non-Invasive(NIV) module, "Right stenosis" appeared in the sentence display within the printed representation of the report.
- Action taken
- AGFA Healthcare sent an Urgent Field Safety Notice dated July 10, 2012, to all affected consignees indicating that a representative from the IMPAX CV product management or professional services team would be contacting them to perform a review of their system. For questions customers were asked to call 401-604-2180. For questions regarding this recall call 864-421-1754.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 6
- Distribution
- Nationwide Distribution including IN, SC, OH, TX
- Date initiated
- 2012-07-10
- Date posted
- 2012-07-24
- Date terminated
- 2013-10-29
- Location
- Greenville, SC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AGFA HEARTLAB CARDIOVASCULAR (K050228) | Heartlab, Inc. | 2005-02-18 |