OEC 9900 Elite MD Motorized C-Arm System, image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT.
FDA Recall Z-0679-2007 · Posted 2007-09-28
Recalling FirmGE OEC Medical Systems, Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2007-03-01
Date Terminated2012-05-01
Product Quantity5 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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.