Agfa IMPAX CardioVascular Suite Results Management Nuclear Reporting Module, Outbound Report, Model/Catalog No.: L7W1P,
FDA device recall Z-1349-2008 · posted 2008-03-31 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- Reporting Differences: The Outbound Report software produces an Outbound Report (text version) which does not contain all the clinical content elements present in the PDF version of the report, also generated on the Nuclear Cardiology Reporting Module.
- Action taken
- All five (5) sites utilizing this product were notified about the issue directly via telephone. An "Urgent Safety Notice" was sent via FED-EX to all the sites using the product on February 22, 2008. The letter describes the potential issue and mitigation. The recalling firm will also visit each site and make configuration changes to resolve this issue.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 5 units
- Distribution
- Nationwide to five hospitals in DC, NY, OH, TN, and VA.
- Date initiated
- 2008-02-22
- Date posted
- 2008-03-31
- Date terminated
- 2010-07-27
- 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 |