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SCANCOAT

DOMICO MED-DEVICE, LLC · Model 409-SCB · UDI-DI 00810050241908

IWYCCX
10
510(k) clearances
17
Adverse events (2 deaths)
1
Recalls
28
Facilities

Description

SCANCOAT®, IMMOBILIZER, NUCLEAR AP HEAD, WITH STRAP

Recalls

DateFirmReason
2007-06-05Brainlab AGTarget 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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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.