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Terminated

OEC 9800, fluoroscopic x-ray system

FDA Recall Z-2629-2016 · Posted None

Recalling FirmGE OEC Medical Systems, Inc
Recall StatusTerminated
Product CodeOWB
Date Initiated2016-07-22
Date Terminated2016-12-19
Product Quantity47 total

Reason for Recall

A firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monitor(s) may appear dark with no video displayed.

Firm Action

On July 22, 2016 GE Healthcare Surgery began distributing an Urgent Medical Device Correction letter to customers via mail to inform them of the issue and provide instructions for immediate mitigation of the issue. The letter was sent to 3 titles at each facility affected: 1.) Facility Administrator, 2.) Director/Manager of Radiology and Radiologists, 3.) Radiology Department. Consignees instructured that local GE Healthcare Field Engineer will contact them to coordinate replacement of the affected monitor(s), and will ensure that system meets specifications.

Root Cause

Software design (manufacturing process)

Distribution Pattern

Distribution US nationwide and Korea.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111551OEC(R) 9800, OEC(R) 9800 PLUSGe Oec Medical Systems, Inc. · 2011-10-04K022069OEC FLUOROTRAK 9800 PLUSGe Oec Medical Systems · 2002-09-17K021049OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEMGe Oec Medical Systems · 2002-04-17K993687UROVIEW 2800Ge Dec Medical Systems · 1999-12-21K974355INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS)Ge Dec Medical Systems · 1998-02-17

Official Source

View FDA Recall →

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

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