Medical Device Recall: Z-0035-2014

FDA Recalls dataset · Firm: AGFA Corp. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2013-09-19 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0035-2014.

Recall Res Number
Z-0035-2014
Recalling Firm / Manufacturer
FEI Number
3001236302
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2013-09-19
Date Posted
2013-10-21
Date Terminated
2013-10-24
Product Code
LLZ
Event Number
66424
Product Quantity
4
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

Related Establishments / Registrations

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.

Account Required Full available specs will require a free AvaSpecs account.