Device recall: 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…

Class II FDA enforcement event 64529. Recall start date: 7 Feb 2013. Status in the FDA record: Terminated. Termination date: 6 Jun 2013.

Reason for recall, in the words of FDA

The cassettes were shipped with the wrong IP (image plate) size bar code.

Class II, in the words of FDA

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

AGFA Corp. started this device recall on 7 Feb 2013. The firm address in the FDA record is in Greenville, SC. FDA put the recall in Class II. FDA event 64529 has 1 product record. The first FDA enforcement report date is 27 Mar 2013. The record gives the status Terminated, with the termination date 6 Jun 2013.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

USA Nationwide Distribution including the states of: AL, CA, FL, IN, MN, NE, NV, OH, SC and UT.

Recalling firm

AGFA Corp., Greenville, SC.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 64529: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0970-2013	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 cassette, used to capture images from X-Ray exposures. The cassette with the image plate, once exposed, is inserted in the Agfa Digitizer CR 10-X where the image plate is taken out of the cassette…	17	Class II	Terminated	27 Mar 2013

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2013: 1,236
Share of these events in Class II: 90%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 11

Other events of the firm

Other FDA enforcement events of 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
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
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

AGFA Corp.: all 11 events

Official channels

FDA enforcement report Z-0970-2013The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 64529. https://recallregister.com/fda/ii/64529/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: USA Nationwide Distribution including the states of: AL, CA, FL, IN, MN, NE, NV, OH, SC and UT.
What quantity of product is in FDA event 64529?: The FDA record gives this quantity: 17
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2013 have the same class?: 90% of the 1,236 device events that started in 2013 are in Class II.