AGFA Corp. IMPAX 4.5 Systems, used in the acceptance, transfer, display, storage and digital processing of medical images. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
IMPAX 4.5 Systems, used in the acceptance, transfer, display, storage and digital processing of medical images.
Brand
AGFA Corp.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
All Impax 4.5 sites running Solaris 9 (Sun OS 5.9) that do not have Sun Patch ID 118305-08 installed.
AGFA Corp. is recalling IMPAX 4.5 Systems, used in the acceptance, transfer, display, storage and digital processing of medi due to Possible corrupted image appearing after System Start.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Possible corrupted image appearing after System Start.
Recommended Action
Per FDA guidance
On 06/30/2006 Agfa upgraded the Software on the installed units using a Mandatory Service Bulletin DD+DIS225.06E.
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
NY
Page updated: Jan 10, 2026