N/A

DOMICO MED-DEVICE, LLC · Model 9411 · UDI-DI 00810050243490

510(k) clearances

Adverse events (2 deaths)

Recalls

Facilities

Description

KIT, TOSHIBA INFINIX HEADHOLDER ACCESSORY. Includes: 9402 - INFINIX MANDIBULAR SUPPORT PADS (10810050242735), 9403 - INFINIX FOREHEAD PAD & STRAP (00810050243223), 9404 - INFINIX CHIN STRAP (00810050241311), 9405 - INFINIX NECK SUPPORT PADS (00810050243230), 9408 - INFINIX HEAD SUPPORT PAD (00810050241328)

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.