IMPAX CardioVascular (CV) Admin Tool The IMPAX Cardiovascular suite is a cardiovascular information system providing ima

FDA device recall Z-0272-2012 · posted 2011-11-23 · Terminated

Recall details

Recalling firm

AGFA Corp.

Reason for recall

Potential for misattribution of data and for a report to become unavailable when the user requests for it to be moved to another study that already has a report associated with it.

Action taken

An 'URGENT FIELD SAFETY NOTICE" was sent via FED-EX by June 6, 2011 to all the sites using the affected product. The letter described the issue and mitigation. The letter recommends that users not move reports to studies where a report already exists. If a report is being moved because the existing report is irrelevant to the study, then the existing report should be deleted prior to moving the new report to that study. If the report is being moved because the user wants to combine the content of the reports, then the "merge" function should be utilized. The letter also states that a software enhancement is currently available. Acknowledgment via FAX-Back was requested from the sites. Questions regarding the issue should be directed to customers' local Agfa HealthCare Service at 877-777-2432. The firm has identified 185 additional sites and an "URGENT FIELD SAFETY NOTICE" was sent on October 12, 2012.

Root cause

Software design

Status

Terminated

Product code

LLZ

Quantity affected

323 units

Distribution

Worldwide Distribution -- USA, Virgin Islands and Canada

Date initiated

2011-06-06

Date posted

2011-11-23

Date terminated

2012-06-26

Location

Greenville, SC

Related 510(k) clearances