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.
FDA Recall Z-0352-06 · Posted 2006-01-06
Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeKPR
Date Initiated2005-11-18
Date Terminated2012-01-12
Product Quantity1059 units
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.
Firm Action
Consignees were notified by letter on/about December 1, 2005.
Root Cause
Other
Distribution Pattern
Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.