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DOMICO MED-DEVICE, LLC · Model 2 · UDI-DI 00810050243254

510(k) clearances

Adverse events (2 deaths)

Recalls

Facilities

Description

KIT, LARGE. Includes: 100 - BLOCK, TORSO, 7” x 12” x 16” (00810050243049), 101 - BLOCK, BASALAR, 7” x 16” x 12” (00810050240987), 102 - HOLDER, ADULT AP-PA HEAD (00810050241205), 104 - BLOCK, PRESSURE, 5.5” x 7.38” x 10” (00810050241069), 105 - WEDGE, 3.75” x 9” x 8” (10810050242995), 106 - WEDGE, 6.63” x 6.63” x 12” (00810050242318), 169 - RECTANGLE, 3” x 7.5” x 10” (00810050240413)

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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.