IMPAX Cardiovascular Polling Procedure version 1.00.09, used in IMPAX 6.2.1 and 6.3.1.; Catalog numbers: E18R4000, L5NQJ
FDA device recall Z-0945-2009 · posted 2009-02-03 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- Polling procedure may fail when multiple merge/split is carried out.
- Action taken
- All sites potentially affected by this product were notified of the issue directly via telephone. Each site was directed to observe a ten minute polling window as an interim mitigation until the normal mitigation by software Service Update is performed at the site by Agfa Support. An Urgent Safety Notice was sent via FED-EX on/about 12/24/2008 to all sites. The letter describes the potential issue and both interim and formal mitigation. Acknowledgment, via FAX-Back, that the information was received and understood was requested from the sites.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 5 units
- Distribution
- Nationwide Distribution --- including states of FL, IL, OR, SC, and SD.
- Date initiated
- 2008-12-24
- Date posted
- 2009-02-03
- Date terminated
- 2010-04-01
- 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 |
| IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO (K022292) | Agfa Corp. | 2002-09-12 |