Z-0855-06

CR DX-S, DX-S, Computed radiography system (Digitizer)

Name: Z-0855-06 CR DX-S, DX-S, Computed radiography system (Digitizer)
Creator: AGFA Corp.
Published: 2005-11-03
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2005-11-03 / Terminated

FDA source

AGFA Corp. began a recall of CR DX-S, DX-S, Computed radiography system (Digitizer) on 2005-11-03. The reason FDA records is "Corrupted image after system start; Corrupted image after workflow interruption; An erasure unit problem can cause system to stop". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0855-06
Status: Terminated
Initiated: 2005-11-03
Posted: 2006-05-09
Terminated: 2006-06-20
Recalling firm: AGFA Healthcare Corp.
Product: CR DX-S, DX-S, Computed radiography system (Digitizer)
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: Corrupted image after system start; Corrupted image after workflow interruption; An erasure unit problem can cause system to stop.
FDA root cause: Other
Action: Consignees were notified at the time of upgrading. The software was upgraded on 11/3/2005, 12/19/2005 and 12/28/2005. A Mandatory Service Bulletin, No. 11, explaining the issues was shared with the accounts.
Quantity in commerce: 3 units
Distribution: DC, MS, OR--three states
Product codes and lots: CR DX-S: Units with Serial numbers SN1001-SN1079, Software versions: STR1102B 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)