Recall Z-2081-2014— AGFA Corp.

Name: FDA recall Z-2081-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-06

Class II · Terminated

Class II FDA medical device recall by AGFA Corp., initiated 2014-06-06, terminated 2016-06-27. It names one FDA 510(k) clearance: K103597. Product: AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts. Agfa's DX-D 100 is not indicated for use in mammography.. Reason: When liquid comes in contact with the DX-D 100 touch screen, the device may incorrectly recognize this as user input altering device settings..

Recalling firm: AGFA Corp.
Classification: Class II
Status: Terminated
Initiated: 2014-06-06
Terminated: 2016-06-27
Firm location: Greenville, SC, United States

510(k) clearances named in this recall

1 on FDA's record

K103597 — DX-D 100Agfa Healthcare N.V.·cleared 2011-01-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts. Agfa's DX-D 100 is not indicated for use in mammography.

Reason for recall

When liquid comes in contact with the DX-D 100 touch screen, the device may incorrectly recognize this as user input altering device settings.

Data sourced from openFDA. This site is unofficial and independent of the FDA.