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Terminated

OEC 9800 image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT.

FDA Recall Z-0677-2007 · Posted 2007-09-28

Recalling FirmGE OEC Medical Systems, Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2007-03-01
Date Terminated2012-05-01
Product Quantity1857 units

Reason for Recall

During routine service, primary and/or secondary collimators may not have been properly reinstalled.

Firm Action

Customers were notified by letter on 03/01/2007. They were told to continue using the machines and that an inspection would be scheduled immediately to verify that collimators had been correctly installed.

Root Cause

Other

Distribution Pattern

Nationwide and Germany.

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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