Recall Z-2184-2012— AGFA Corp.

Name: FDA recall Z-2184-2012
Creator: U.S. Food and Drug Administration
Published: 2012-07-27

Class II · Terminated

Class II FDA medical device recall by AGFA Corp., initiated 2012-07-27, terminated 2015-01-13. It names one FDA 510(k) clearance: K050228. Product: IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF). Reason: Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report..

Recalling firm: AGFA Corp.
Classification: Class II
Status: Terminated
Initiated: 2012-07-27
Terminated: 2015-01-13
Firm location: Greenville, SC, United States

510(k) clearances named in this recall

1 on FDA's record

K050228 — AGFA HEARTLAB CARDIOVASCULARHeartlab, Inc.·cleared 2005-02-18

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 Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)

Reason for recall

Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report.

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