GE OEC 9900 Elite Digital Mobile C-Arm X-ray system, GE OEC Medical Systems Inc.
This recall has been terminated (originally issued September 30, 2006).
- Company
- Ge Oec Medical Systems, Inc
- Recall Initiated
- August 16, 2006
- Posted
- September 30, 2006
- Terminated
- July 27, 2011
- Recall Number
- Z-1301-06
- Quantity
- 202 units (US), 26 units (Foreign)
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
X-ray systems could provide output which exceeds the 20 R/minute limit.
Distribution
Worldwide
Lot / Code Info
All units.
Root Cause
Other
Action Taken
Consignees were notified by certified letter on 08/14-15/2006.
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