Recall Z-1662-2014— AGFA Corp.

Name: FDA recall Z-1662-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-30

Class II · Terminated

Class II FDA medical device recall by AGFA Corp., initiated 2014-04-30, terminated 2014-09-18. It names one FDA 510(k) clearance: K050228. Product: IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.. Reason: Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service..

Recalling firm: AGFA Corp.
Classification: Class II
Status: Terminated
Initiated: 2014-04-30
Terminated: 2014-09-18
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 CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.

Reason for recall

Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service.

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