FDA Device

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

Hazard

Corrupted image after system start; Corrupted image after workflow interruption; An erasure unit problem can cause system to stop.

What You Should Do

Remedy

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.

Products

CR DX-S, DX-S, Computed radiography system (Digitizer)
Brand
AGFA Corp.
UPC
CR DX-S: Units with Serial numbers SN1001-SN1079, Software versions: STR1102B and below.

Units Affected

3 units