GE OEC 2800 mobile Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah.
FDA Recall Z-0852-2007 · Posted 2007-06-30
Recalling FirmGE OEC Medical Systems, Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2007-06-12
Date Terminated2011-11-01
Product Quantity25 units
Reason for Recall
X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma.
Firm Action
Consignees were notified by letter on 06/12/2007 and told that a service representative would arrange for an inspection and would modify their systems.
Root Cause
Other
Distribution Pattern
Worldwide Distribution: USA including states of FL, GA, PA. CO, MD, VA and WA. and countries of Australia, Austria, Belgium, Brazil, Canada, Colombia, Finland, France, Germany, Hong Kong, India, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Norway, Portugal, Switzerland, Taiwan, and the 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.