Recall Z-0219-2007 ยท MBQ Peripheral Electromagnetic Field (Pemf) To Aid Wound Healing
AGFA Corp.
CR NX Modality Workstation, Computed Radiography System (Software versions NX 1.0.2402 and NX 1.0.2405).
| Date | Nov 28, 2006 (initiated Sep 1, 2006) |
| Status | Terminated |
| Reason | 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. |
| 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 | 178 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.