Z-1307-2008

Impax 4.5, Impax 5.0, Impax 5.2 and Impax 5.2x Picture Archiving Systems (PACs) with integrated Voxar 3D...

Name: Z-1307-2008 Impax 4.5, Impax 5.0, Impax 5.2 and Impax 5.2x Picture Archiving Systems (PACs) with integrated Voxar 3D...
Creator: AGFA Corp.
Published: 2007-02-15
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2007-02-15 / Terminated / root cause: software

FDA source

AGFA Corp. began a recall of 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... on 2007-02-15. The reason FDA records is "Misidentification: The orthopedic planning X-ray images for one patient are misidentified as the images for another patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1307-2008
Status: Terminated
Initiated: 2007-02-15
Posted: 2008-07-02
Terminated: 2009-06-30
Recalling firm: AGFA Healthcare Corp.
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
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Misidentification: The orthopedic planning X-ray images for one patient are misidentified as the images for another patient.
Root cause tag: software
FDA 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 in commerce: 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.
Product codes and lots: 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.

Product code LLZ

K022292Class IIImpax Diagnostic Display Station,impax Clinical Review Station,impax for Cardiology Clinical Review Satation,impax OrthoAgfa Corp. / cleared 2002-09-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)