Recall Z-1487-2013— AGFA Corp.

Name: FDA recall Z-1487-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-15

Class II · Terminated

Class II FDA medical device recall by AGFA Corp., initiated 2013-05-15, terminated 2014-12-31. 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.. Reason: Customers could potentially experience intermittent, unintended and illogical movement when using the product..

Recalling firm: AGFA Corp.
Classification: Class II
Status: Terminated
Initiated: 2013-05-15
Terminated: 2014-12-31
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.

Reason for recall

Customers could potentially experience intermittent, unintended and illogical movement when using the product.

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