Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor, MI
FDA device recall Z-0826-2008 · posted 2008-02-07 · Terminated
Recall details
- Recalling firm
- Xoran Technologies, Inc.
- Reason for recall
- Misbranding; These devices do not bear the manufacturer's name or address.
- 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.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 71
- Distribution
- Nationwide.
- Date initiated
- 2008-01-04
- Date posted
- 2008-02-07
- Date terminated
- 2010-10-22
- Location
- Ann Arbor, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MINICAT DENTOCAT (K032243) | Xoran Technologies, Inc. | 2003-10-02 |