AGFA Corp.: Medical Device Recall in 2013 - (Recall #: Z-1069-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management.

Product Classification:

Class II

Date Initiated: March 15, 2013

Date Posted: April 17, 2013

Recall Number: Z-1069-2013

Event ID: 64654

Reason for Recall:

Software design error in IMPAX CV 7.8 SU3

Status: Terminated

Product Quantity: 2

Code Information:

Softwaer version: IMPAX CR 7.8 SU3 Optical Character Recognition (OCR) Service

Distribution Pattern:

Distribute in the state of FL and KY

Voluntary or Mandated:

Voluntary: Firm initiated