Skip to content
Recall Observatory FDA recall evidence

Device product

IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).

Z-0035-2014

September 19, 2013

Class II

Product summary

Firm
AGFA Corp.
Event
Event 66424
Status
Terminated
Classification
Class II
Quantity
4
Official record key
device-enforcement:Z-0035-2014

Official wording

Reason: System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels.

Code information: N/A

Distribution pattern: Worldwide distrbution: US(nationwide) distribution including NY and OK, and country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels.