19" Barco MFCD 1219 (Touch Screen) + Low Profile Stand and Rack with LCD Arm Agfa's Computed Radiography Systems with NX
FDA device recall Z-2100-2010 · posted 2010-07-26 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- Monitor fell from the mounting bracket used to support the monitor.
- Action taken
- The firm, AGFA Healthcare sent an 'URGENT SAFETY NOTICE" dated June 30, 2010, via FED-EX to customers. The letter describes product, problem and actions to be taken by the firm and customers. AGFA will provide a safety check to the customers facility, have a service representative visit , in the near future, their site to inspect the monitor/s and attach a warning label on each monitor checked for preventative action. The customers are ask to distribute the information within their facility to all individuals who need to be aware, to complete the attached URGENT SAFETY NOTICE FEEDBACK FORM as soon as possible and return via fax at 864-421-1664. If you have any questions about this matter, please feel free to contact me via email at Debbie.norris@agfa.com or call me at 864-421-1754.
- Root cause
- Other
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 805 units
- Distribution
- Worldwide distribution: USA and countries of Puerto Rico and Canada.
- Date initiated
- 2010-06-30
- Date posted
- 2010-07-26
- Date terminated
- 2011-04-28
- 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 |
|---|---|---|
| AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS (K071162) | Agfa Healthcare Corp. | 2007-05-08 |