CR NX Modality Workstation, Computed Radiography System (Software versions NX 1.0.2402 and NX 1.0.2405).
FDA device recall Z-0219-2007 · posted 2006-11-28 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- Reason for recall
- Users may experience one or more of four (4) problems; 1. Image quality problem with full leg full spine exams. 2. Unable to print 2 or more images on 1 film. 3. Possible image loss when printing. 4. Study date and time not showing up on Imexius Web.
- Action taken
- A Service Bulletin to address the issues was created on 09/01/2006. Customers were notified of the plans to upgrade via telephone and email on 10/13/2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- MBQ
- Quantity affected
- 178 units
- Distribution
- Nationwide
- Date initiated
- 2006-09-01
- Date posted
- 2006-11-28
- Date terminated
- 2008-04-24
- Location
- Greenville, SC
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