Product Description
IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).
Reason for Recall
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.
Action Details
An "URGENT FIELD SAFETY NOTICE" letter was sent via email to the consignees on 9/19/2013, Acknowledgement, via FAX-Back or email, that the information was received and understood has been requested from the consignees. The letter specifically describes the safety alert for the device, informs consignees of the problem and recommends the upgrades for IMPAX and Oracle.
Distribution Pattern
Worldwide distrbution: US(nationwide) distribution including NY and OK, and country of Canada.
Code Information / Serial Numbers
N/A
Public Record Disclaimer
This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.