FDA Device

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.

Hazard

Users of affected systems may experience a loss of images, the need to repeat the imaging procedure and possibly a short delay in diagnosis.

What You Should Do

Remedy

Consignees were notified by letter on/about December 1, 2005.

Products

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.
Brand
AGFA Corp.
UPC
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.

Units Affected

1059 units