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DOMICO MED-DEVICE, LLC · Model 9007 · UDI-DI 00810050242134
10
510(k) clearances
17
Adverse events (2 deaths)
1
Recalls
28
Facilities
Description
STRAP, FOREHEAD W/ADULT PAD. Includes: 9007-A - PAD, FOREHEAD .50” x 2” x 6” (00810050241434), 9007-B - STRAP, FOREHEAD, 2” x 23” (00810050242127)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2007-06-05 | Brainlab AG | Target Alignment Error : A mechanical component/software incompatibility caused by a specific combination of the BrainLAB Target Positioner version 40700-3A for Leksell headrings a |
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