IMPAX 4.5 Systems, used in the acceptance, transfer, display, storage and digital processing of medical images.
FDA Recall Z-1256-06 · Posted 2006-07-27
Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2006-06-30
Date Terminated2006-09-05
Product Quantity2 units
Reason for Recall
Possible corrupted image appearing after System Start.
Firm Action
On 06/30/2006 Agfa upgraded the Software on the installed units using a Mandatory Service Bulletin DD+DIS225.06E.
Root Cause
Other
Distribution Pattern
NY
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.