Electrophysiology Imaging System
FDA Recall Z-1525-05 · Posted 2005-09-09
Recalling FirmFischer Imaging Corporation
Recall StatusTerminated
Product CodeJAA
Date Initiated2005-04-28
Date Terminated2012-03-13
Product Quantity51 units
Reason for Recall
Belt driving the Image Intensifier may break, causing the Intensifier to slip down, possibly causing injury to patient.
Firm Action
Consignees were notified by certified letter on 04/27/2005.
Root Cause
Other
Distribution Pattern
Nationwide, including VA facilities in GA and TX. Foreign distribution to Australia, Mexico and Poland. No military distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.