OEC Miniview 6800 mobile fluoroscopic x-ray system, GE Healthcare, Surgery, Salt Lake City, Utah.
FDA Recall Z-0928-2007 · Posted 2007-07-03
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Recalling FirmOEC Medical Systems, Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2007-05-24
Date Terminated2008-06-02
Product Quantity811 systems
Reason for Recall
X-ray systems did not have the required labeling to indicate Air Kerma Rate and cumulative Air Kerma during fluoroscopic procedures
Firm Action
Consignees were notified by letter on 05/24/2007 and advised that a service representative would be contacting them for installation of the required label and to provide them with an update to their user's manuals.
Root Cause
Other
Distribution Pattern
Worldwide; USA including VA facilities in AK, CA, ID, MD, MI, NY and OR. Military distribution to CA, CO, CT, FL, GA, KS, LA, MS, OH, OK, TX, VA and Iraq. Foreign distribution to Austria, Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Japan, Korea, Malaysia, Netherlands, Norway, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan and UK.
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.
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