Z-0353-06

CR QS (versions 3.0.207, 2.0.210 SU1, 3.0.229) ADC QS and Centricity CR Online Processing Software (version...

Name: Z-0353-06 CR QS (versions 3.0.207, 2.0.210 SU1, 3.0.229) ADC QS and Centricity CR Online Processing Software (version...
Creator: AGFA Corp.
Published: 2005-11-18
License: https://open.fda.gov/license/

AGFA Healthcare Corp. / initiated 2005-11-18 / Terminated

FDA source

AGFA Corp. began a recall of CR QS (versions 3.0.207, 2.0.210 SU1, 3.0.229) ADC QS and Centricity CR Online Processing Software (version 2.x) on 2005-11-18. The reason FDA records is "Users of affected systems may experience one or more of four (4) problems the clinical impact could be a loss of image(s), the need to repeat the imaging procedure and, possibly, a short delay in diagnosis". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0353-06
Status: Terminated
Initiated: 2005-11-18
Posted: 2006-01-06
Terminated: 2009-06-30
Recalling firm: AGFA Healthcare Corp.
Product: CR QS (versions 3.0.207, 2.0.210 SU1, 3.0.229) ADC QS and Centricity CR Online Processing Software (version 2.x)
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Users of affected systems may experience one or more of four (4) problems the clinical impact could be a loss of image(s), the need to repeat the imaging procedure and, possibly, a short delay in diagnosis.
FDA root cause: Other
Action: Consignees will be notified by letter on/about December 1, 2005 and offered upgraded software.
Quantity in commerce: 2630 units
Distribution: Nationwide
Product codes and lots: Software versions: ADC QS 2.0, CR QS 3.O.207, CR QS 3.O.210, CR QS 3.0.210SU1, CRQS 3.0.229, Centricity CR Online Processing software 2.x.

Product code LLZ

K010571Class IIAdc Qs/ipd WorkstationAgfa Corp. / cleared 2001-03-28

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)