Device recall: IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPA

FDA enforcement event 68211 · Class II · initiated 30 Apr 2014 · status Terminated · terminated 18 Sep 2014

DeviceVoluntary: Firm initiated1 product recordGreenville, SC

FDA enforcement event 68211 is a device recall by AGFA Corp. of Greenville, SC, initiated 30 Apr 2014 and classified Class II, with 1 product record.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.

Status: Terminated, terminated 18 Sep 2014. Initiation: voluntary: firm initiated. AGFA Corp. has 11 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

AGFA Corp., Greenville, SC.

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."

Distribution

"Distribution to SC only"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1662-2014	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.	One	Class II	Terminated	4 Jun 2014

Context

91%of 2014 device events are Class II1,176 events that year

1product record in this eventfirm median: 1

11events on this register for the firm

Other enforcement events for AGFA Corp.

Initiated	Product (first record)	Type	Class	Records
6 Jun 2014	AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality imag	Device	Class II	1
8 Jan 2014	IMPAX RIS QDOC 5.8	Device	Class II	1
19 Sep 2013	IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).	Device	Class II	1
15 May 2013	AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality imag	Device	Class II	1
15 Mar 2013	IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for cathe	Device	Class II	1
15 Mar 2013	IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital s	Device	Class II	1
7 Feb 2013	CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate, contained in an X-Ray c	Device	Class II	1
9 Aug 2012	AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS),	Device	Class II	1
27 Jul 2012	IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (includin	Device	Class II	1
10 Jul 2012	IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of	Device	Class II	1

All 11 events for AGFA Corp.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Distribution to SC only"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 18 Sep 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.