NX 2008 Central Monitoring System (CMS). Product code: E2FB6 Agfa's Computed Radiography Systems with NX Workstations ar
FDA device recall Z-1889-2009 · posted 2009-09-02 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- After opening and closing a study on a Central Monitoring System while a study is still open on an in-room NX system, a problem of image mix-up can occur on the in-room NX system.
- Action taken
- An "Urgent Safety Notice" was sent to all potentially affected sites on/about June 22, 2009 to make them aware of the issue. A FAX Back form is requested with each letter to ensure someone at the account acknowledges the information was received and understood. If a FAX Back form is not received, the account will be contacted by telephone. A software service update to solve this issue is expected to be released by August 15, 2009. A Mandatory Service Bulletin will be deployed to correct the problem in the software. If you have questions, please contact Agfa Healthcare at 1-800-581-2432 prompts 1, 3 and then 2 for CR Support.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 97 units
- Distribution
- Worldwide - IL, PA, TX, Canada, Europe, Asia Pacific and Latin America
- Date initiated
- 2009-06-22
- Date posted
- 2009-09-02
- Date terminated
- 2010-07-22
- 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 SYSTEMS WITH NX WORKSTATIONS (K090672) | Agfa Healthcare N.V. | 2009-05-18 |