NA

DOMICO MED-DEVICE, LLC · Model 9405 · UDI-DI 00810050243230

510(k) clearances

Adverse events (2 deaths)

Recalls

Facilities

Description

INFINIX NECK SUPPORT PADS. Includes: 21574 - SUPPORT, SMALL NECK, .75 X 1.50 X 4.93 (00810050243018), 21575 - SUPPORT, MEDIUM NECK, 1.00 X 2.00 X 5.60 (00810050243025) , 21576 - SUPPORT, LARGE NECK, 1.13 X 2.25 X 5.89 (00810050243032)

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.