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Terminated

OEC 9800 Image Intensified fluoroscopic x-ray system (includes OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, and OEC 9800MD Motorized C-arm System), GE Healthcare, Surgery, Salt Lake City, UT.

FDA Recall Z-1705-2008 · Posted 2008-09-01

Recalling FirmOEC Medical Systems, Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2008-04-15
Date Terminated2011-12-21
Product Quantity78 units

Reason for Recall

Use of existing four-pedal footswitch on a different machine may cause various operational errors.

Firm Action

Consignees were notified by letter on 03/21/2007 and advised that GE would be replacing the 4-pedal switches at some time in the future. Replacement began on 04/15/2008. Contact GE Healthcare at 1-800-874-7378 for assistance.

Root Cause

Device Design

Distribution Pattern

Nationwide, including one VA facility in FL. No military or foreign distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K024012OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEMGe Oec Medical Systems · 2003-03-20K022069OEC FLUOROTRAK 9800 PLUSGe Oec Medical Systems · 2002-09-17K021049OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEMGe Oec Medical Systems · 2002-04-17

Official Source

View FDA Recall →

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

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