AGFA Corp. CR DX-S, DX-S, Computed radiography system (Digitizer) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CR DX-S, DX-S, Computed radiography system (Digitizer)
Brand
AGFA Corp.
Lot Codes / Batch Numbers
CR DX-S: Units with Serial numbers SN1001-SN1079, Software versions: STR1102B and below.
Products Sold
CR DX-S: Units with Serial numbers SN1001-SN1079, Software versions: STR1102B and below.
AGFA Corp. is recalling CR DX-S, DX-S, Computed radiography system (Digitizer) due to Corrupted image after system start; Corrupted image after workflow interruption; An erasure unit problem can cause system to stop.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Corrupted image after system start; Corrupted image after workflow interruption; An erasure unit problem can cause system to stop.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MS, OR, DC
Page updated: Jan 10, 2026