Z-0031-2007

CR DX-S, Image Intensified Fluoroscopic X-ray system

Name: Z-0031-2007 CR DX-S, Image Intensified Fluoroscopic X-ray system
Creator: AGFA Corp.
Published: 2006-06-28
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2006-06-28 / Terminated

FDA source

AGFA Corp. began a recall of CR DX-S, Image Intensified Fluoroscopic X-ray system on 2006-06-28. The reason FDA records is "Three separate issues involving the Agfa DX-S CR System, were detected that could lead to an image loss". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0031-2007
Status: Terminated
Initiated: 2006-06-28
Posted: 2006-10-12
Terminated: 2007-05-10
Recalling firm: AGFA Healthcare Corp.
Product: CR DX-S, Image Intensified Fluoroscopic X-ray system.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: Three separate issues involving the Agfa DX-S CR System, were detected that could lead to an image loss.
FDA root cause: Other
Action: Consignees were notified by letter on/about 06/28/2006.
Quantity in commerce: 11 units
Distribution: CA, DC, FL, MN, MI, MS, OR.
Product codes and lots: Units with Serial number SN1001- SN1179, and SN1181, SN1183 and SN1184; Software versions: STR_1207 and below.

Product code MQB

K050810Class IIAgfa Cr50.0Agfa Corp. / cleared 2005-04-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)