Recall Z-1307-2008 ยท LLZ System, Image Processing, Radiological
AGFA Corp.
Impax 4.5, Impax 5.0, Impax 5.2 and Impax 5.2x Picture Archiving Systems (PACs) with integrated Voxar 3D software; and Impax 5.0 and Impax 5.2 PACs with integrated MediCAD software. The softwares are used to provide digital X-ray images for pre-surgical orthopedic planning. AGFA Corp., Greenville, South Carolina 29601
| Date | Jul 2, 2008 (initiated Feb 15, 2007) |
| Status | Terminated |
| Reason | Misidentification: The orthopedic planning X-ray images for one patient are misidentified as the images for another patient. |
| Root cause | Software design |
| Action | On 2/15/07, AGFA notified their consignees of the situation by sending them "Urgent Medical Device Correction" letters, instructing them on how to work around the problem until the firm was able to install the upgraded software that corrected the problem. On 12/11/2007, the firm reported that the upgraded software had been installed at all affected sites. |
| Quantity | 879 units |
| Distribution | Worldwide Distribution - USA including states of AR, AZ, CA, CO, DC, FL, GA, IL, IN, KY, KS, MA, MD, ME, MI, NC, NJ, NV, NY, NV, OH, OK, PA, SC, TN, TX, UT, VA and WA, and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022292 | IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO Agfa Corp., Sep 12, 2002 |