RecallDepth

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

This recall has been terminated (originally issued May 9, 2006).

Company
Agfa Corp.
Recall Initiated
November 3, 2005
Posted
May 9, 2006
Terminated
June 20, 2006
Recall Number
Z-0855-06
Quantity
3 units
Firm Location
Greenville, SC
Official Source
View on FDA website ↗

Reason for Recall

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

Distribution

DC, MS, OR--three states

Lot / Code Info

CR DX-S: Units with Serial numbers SN1001-SN1079, Software versions: STR1102B and below.

Root Cause

Other

Action Taken

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.

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