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PhotonGuide XT System

INVUITY, INC. · Model Narrow / Angled · UDI-DI 00816728020110

FDG Prescription
2
510(k) clearances
89
Adverse events
2
Recalls
76
Facilities

Description

The PhotonGuide XT System is intended to provide surgical site illumination from a high intensity light source.

Recalls

DateFirmReason
2009-07-01Lumitex IncAdhesive which is used to attach LightMat to retractor may not have been tested to Medical standards. The vendor provided an adhesive strip that did not conform to Lumitex specifi
2008-10-24Biomet Microfixation, Inc.Fiber optic cable is missing from the Frederick's Converse Retractor Lot # 042408D08.

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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.