RecallRadar

FDA Device recall Z-0035-2014

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

On 2013-10-30 the FDA classified a Class II recall of IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS) by Agfa, citing 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.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0035-2014
ClassificationClass II
Statusterminated
Initiated2013-09-19
Published2013-10-30
Last updated2026-09-13 11:53 UTC
CompanyAgfa
DistributionUS

Product

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

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.

Identifiers

code_infoN/A

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0035-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.