Recall Z-0919-2014— AGFA Corp.

Name: FDA recall Z-0919-2014
Creator: U.S. Food and Drug Administration
Published: 2014-01-08

Class II · Terminated

Class II FDA medical device recall by AGFA Corp., initiated 2014-01-08, terminated 2014-02-28. It names one FDA 510(k) clearance: K111945. Product: IMPAX RIS QDOC 5.8. Reason: Patient name displayed (printed) on the Patient Report was the wrong patient name..

Recalling firm: AGFA Corp.
Classification: Class II
Status: Terminated
Initiated: 2014-01-08
Terminated: 2014-02-28
Firm location: Greenville, SC, United States

510(k) clearances named in this recall

1 on FDA's record

K111945 — IMPAX NEXT GENERATIONAgfa Healthcare N.V.·cleared 2011-08-05

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

IMPAX RIS QDOC 5.8

Reason for recall

Patient name displayed (printed) on the Patient Report was the wrong patient name.

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