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Terminated

Electrophysiology Imaging System

FDA Recall Z-1526-05 · Posted 2005-09-09

Recalling FirmFischer Imaging Corporation
Recall StatusTerminated
Product CodeJAA
Date Initiated2005-04-28
Date Terminated2012-03-13
Product Quantity20 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.

K961207EP-X BIPLANEFischer Imaging Corp. · 1996-08-20K934481EP-XFischer Imaging Corp. · 1993-11-03K912448CSPFischer Imaging Corp. · 1991-08-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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