Z-0219-2007
CR NX Modality Workstation, Computed Radiography System (Software versions NX 1.0.2402 and NX 1.0.2405)
AGFA Healthcare Corp. / initiated 2006-09-01 / Terminated
AGFA Corp. began a recall of CR NX Modality Workstation, Computed Radiography System (Software versions NX 1.0.2402 and NX 1.0.2405) on . The reason FDA records is "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...". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0219-2007
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- AGFA Healthcare Corp.
- Product
- CR NX Modality Workstation, Computed Radiography System (Software versions NX 1.0.2402 and NX 1.0.2405).
- Product code
- MBQ Peripheral Electromagnetic Field (Pemf) To Aid Wound Healing
- 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.
- FDA root cause
- Other
- Action
- 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.
- Quantity in commerce
- 178 units
- Distribution
- Nationwide
- Product codes and lots
- NX Workstation Software is sold in the following packages: 60+0026406, 60+00026407, 60+00026408, 60+00026857, 60+00026858, 60+00026410, ES885. Software versions: NX 1.0.2402 and NX 1.0.2405
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