Z-1524-05

Electrophysiology Imaging System

Name: Z-1524-05 Electrophysiology Imaging System
Creator: Fischer Imaging Corporation
Published: 2005-04-28
License: https://open.fda.gov/license/

Fischer Imaging Corp. / initiated 2005-04-28 / Terminated

FDA source

Fischer Imaging Corporation began a recall of Electrophysiology Imaging System on 2005-04-28. The reason FDA records is "Belt driving the Image Intensifier may break, causing the Intensifier to slip down, possibly causing injury to patient". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1524-05
Status: Terminated
Initiated: 2005-04-28
Posted: 2005-09-09
Terminated: 2012-03-13
Recalling firm: Fischer Imaging Corp.
Product: Electrophysiology Imaging System
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: Belt driving the Image Intensifier may break, causing the Intensifier to slip down, possibly causing injury to patient.
FDA root cause: Other
Action: Consignees were notified by certified letter on 04/27/2005.
Quantity in commerce: 23 units
Distribution: Nationwide, including VA facilities in GA and TX. Foreign distribution to Australia, Mexico and Poland. No military distribution.
Product codes and lots: Model EPX, Product Number 93400G-1

Product code JAA

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)