Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
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