IMPAX RIS QDOC 5.8
FDA device recall Z-0919-2014 · posted 2014-02-03 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- Patient name displayed (printed) on the Patient Report was the wrong patient name.
- Action taken
- On January 8, 2014, an "URGENT FIELD SAFETY NOTICE" (UFSN) letter was emailed to consignees. The letter described the safety alert and mitigation, including directions to consignees as to how the disable Microsoft Word Background Printing. Acknowledgment via FAX-Back or email, that the information was received and understood was requested from the consignees.
- Root cause
- Unknown/Undetermined by firm
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 14
- Distribution
- CA, FL, GA, ME, OH, OR, SC, SD, TX and Canada
- Date initiated
- 2014-01-08
- Date posted
- 2014-02-03
- Date terminated
- 2014-02-28
- 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 |
|---|---|---|
| IMPAX NEXT GENERATION (K111945) | Agfa Healthcare N.V. | 2011-08-05 |