Z-0352-06

ADC Solo & Initia CR 1000, Path Speed CR SP1001, Centricity CR SP1001 and Centricity CR SP 100, image...

Name: Z-0352-06 ADC Solo & Initia CR 1000, Path Speed CR SP1001, Centricity CR SP1001 and Centricity CR SP 100, image...
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 ADC Solo & Initia CR 1000, Path Speed CR SP1001, Centricity CR SP1001 and Centricity CR SP 100, image digitizer, components in Agfa''s computed radiography... on 2005-11-18. The reason FDA records is "Users of affected systems may experience a loss of images, 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-0352-06
Status: Terminated
Initiated: 2005-11-18
Posted: 2006-01-06
Terminated: 2012-01-12
Recalling firm: AGFA Healthcare Corp.
Product: ADC Solo & Initia CR 1000, Path Speed CR SP1001, Centricity CR SP1001 and Centricity CR SP 100, image digitizer, components in Agfa''s computed radiography product line.
Product code: KPR System, X-Ray, Stationary
Reason for recall: Users of affected systems may experience a loss of images, the need to repeat the imaging procedure and possibly a short delay in diagnosis.
FDA root cause: Other
Action: Consignees were notified by letter on/about December 1, 2005.
Quantity in commerce: 1059 units
Distribution: Nationwide
Product codes and lots: Serial Numbers: ADC Solo: Units with Serial numbers les than 4748, Initia CR1000, Path Speed CR SP1001, Centricity CR SP1001 and Centricity CR SP100: all serial numbers are considered affected unless they have been upgraded to software version SOL_2205 or later.

Product code KPR

K974597Class IIAdc Compact (Agfa Diagnostic Center)Bayer Corp., Agfa Div. / cleared 1998-03-09

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)