Device recall: IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).

FDA enforcement event 66424 · Class II · initiated 19 Sep 2013 · status Terminated · terminated 24 Oct 2013

DeviceVoluntary: Firm initiated1 product recordGreenville, SC

FDA enforcement event 66424 is a device recall by AGFA Corp. of Greenville, SC, initiated 19 Sep 2013 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. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.

Status: Terminated, terminated 24 Oct 2013. 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

"System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels."

Distribution

"Worldwide distrbution: US(nationwide) distribution including NY and OK, and country of Canada."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0035-2014	IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).	4	Class II	Terminated	30 Oct 2013

Context

90%of 2013 device events are Class II1,236 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
30 Apr 2014	IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPA	Device	Class II	1
8 Jan 2014	IMPAX RIS QDOC 5.8	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: "System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels."

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: "Worldwide distrbution: US(nationwide) distribution including NY and OK, and country of Canada."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 24 Oct 2013. "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.