N/A

DOMICO MED-DEVICE, LLC · Model 9090 · UDI-DI 00810050243216

510(k) clearances

Adverse events (2 deaths)

Recalls

Facilities

Description

AQUILION ONE HEAD HOLDER KIT. Includes: 9091 - HOLDER, AQUILION ONE CARBON FIBER (00810050241212), 9092 - PAD, AQUILION ONE ADULT HOLDER (00810050241380), 9093 - PAD, AQUILION ONE CHILD HOLDER (00810050241397), 9094 - PAD, AQUILION ONE PEDIATRIC HOLDER (00810050242448), 9095 - PAD, AQUILION ONE WEDGE (00810050241403), 9096 - WEDGE, TAPER, 1.5” x 3.5” x 3” (10810050243008), 9097 - STRAP, VELTEX, 2” x 22” (10810050242896)

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.