NX is the radiographer's image identification and quality control tool. It offers a broad array of features developed es
FDA device recall Z-2137-2011 · posted 2011-05-04 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- When a radiographer is working on two open studies on an NX workstation and, in specific situations, a problem of image/annotation mix-up can occur on the NX system.
- Action taken
- AGFA Corp. sent an "URGENT FIEL SAFETY NOTICE" letter via FED-EX to the customers on March 4, 2011. The letter describes the safety alert and mitigation. Customers were instructed to complete and return the Urgent Field Safety Notice Feedback Form by fax to 864-421-1664. For questions regarding this recall call 864-421-1815.
- Root cause
- Other
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 775 units
- Distribution
- Worldwide Distribution - USA including CA, GA, MS, ND, NM, NY, OK, PA, SC, SD, TX, and VA and the country of Canada
- Date initiated
- 2011-03-04
- Date posted
- 2011-05-04
- Date terminated
- 2012-03-27
- 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 COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS (K071162) | Agfa Healthcare Corp. | 2007-05-08 |