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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
AGFA Corp.
Lot Codes / Batch Numbers
Hectec MediCAD: ETSAN, VOXAR 3D: L72JO, and Impax 4.5 or 5.0 or 5.2 Client /OT3000: A component of Order Codes: 60+00021533, 60+00021534, 60+00022471, 60+00022472, 60+00015451, 60+00015453, 60+00021535 and 60+00024519.
Products Sold
Hectec MediCAD: ETSAN; VOXAR 3D: L72JO; and Impax 4.5 or 5.0 or 5.2 Client /OT3000: A component of Order Codes: 60+00021533, 60+00021534, 60+00022471, 60+00022472, 60+00015451, 60+00015453, 60+00021535 and 60+00024519.
AGFA Corp. is recalling Impax 4.5, Impax 5.0, Impax 5.2 and Impax 5.2x Picture Archiving Systems (PACs) with integrated Vox due to Misidentification: The orthopedic planning X-ray images for one patient are misidentified as the images for another patient.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Misidentification: The orthopedic planning X-ray images for one patient are misidentified as the images for another patient.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, AR, CA, CO, FL, GA, IL, IN, KS, KY, ME, MD, MA, MI, NV, NJ, NY, NC, OH, OK, PA, SC, TN, TX, UT, VA, WA, DC
Page updated: Jan 10, 2026