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
Hazard
Misidentification: The orthopedic planning X-ray images for one patient are misidentified as the images for another patient.
What You Should Do
Remedy
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.
Affected by this recall?
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Products
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 ar
- Brand
- AGFA Corp.
- UPC
- 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.
Units Affected
879 units