OEC Miniview 6800 mobile fluoroscopic x-ray system, GE Healthcare, Surgery, Salt Lake City, Utah.
This recall has been terminated (originally issued July 3, 2007).
- Company
- Oec Medical Systems, Inc
- Recall Initiated
- May 24, 2007
- Posted
- July 3, 2007
- Terminated
- June 2, 2008
- Recall Number
- Z-0928-2007
- Quantity
- 811 systems
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
X-ray systems did not have the required labeling to indicate Air Kerma Rate and cumulative Air Kerma during fluoroscopic procedures
Distribution
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.
Lot / Code Info
Serial numbers in the range of 86-0032 to 86-2161
Root Cause
Other
Action Taken
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.