IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (includin
FDA device recall Z-2184-2012 · posted 2012-08-10 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report.
- Action taken
- AGFA Healthcare sent an URGENT FIELD SAFETY NOTICE dated July 27, 2012, to all affected customers. The letter described the safety alert and mitigation. Customer were asked to complete the Acknowledgment form and fax back to 864-421-1664 that the information was received and understood. For questions customers were instructed tol call 401-604-2180. For questions regarding this recall call 864-421-1754.
- Root cause
- Software change control
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 280
- Distribution
- Worldwide Distribution - USA (nationwide) and Canada
- Date initiated
- 2012-07-27
- Date posted
- 2012-08-10
- Date terminated
- 2015-01-13
- 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 |