Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI
This recall has been terminated (originally issued February 7, 2008).
- Company
- Xoran Technologies, Inc.
- Recall Initiated
- January 4, 2008
- Posted
- February 7, 2008
- Terminated
- October 22, 2010
- Recall Number
- Z-0826-2008
- Quantity
- 71
- Firm Location
- Ann Arbor, MI
- Official Source
- View on FDA website ↗
Reason for Recall
Misbranding; These devices do not bear the manufacturer's name or address.
Distribution
Nationwide.
Lot / Code Info
All units
Root Cause
Labeling design
Action Taken
Consignees were notified via letter, Urgent Medical Device Correction, dated 1/4/08 of the need to apply proper labeling to the products, and were sent instructions and labeling to affix to their units.
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