Recall Z-2176-2014— AGFA Healthcare Corp.

Name: FDA recall Z-2176-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-13

Class III · Terminated

Class III FDA medical device recall by AGFA Healthcare Corp., initiated 2014-05-13, terminated 2014-08-13. It names one FDA 510(k) clearance: K103597. Product: Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.. Reason: Unit was mislabeled with a factory label showing 32 KW output power..

Recalling firm: AGFA Healthcare Corp.
Classification: Class III
Status: Terminated
Initiated: 2014-05-13
Terminated: 2014-08-13
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 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.

Reason for recall

Unit was mislabeled with a factory label showing 32 KW output power.

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