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Gyrus ACMI

Gyrus ACMI, LLC · Model 98-0759 · UDI-DI 00821925008809

FFS Prescription
1
510(k) clearances
340
Adverse events (2 deaths)
2
Recalls
24
Facilities

Description

Light Guide Adapter, M3 Gold (Wolf)

Recalls

DateFirmReason
2017-05-03Cook Inc.Cook Inc. is initiating a voluntary recall of the Vue Optic Visualization Source and the Flexor Vue Deflecting Endoscopic System because it was determined that the current reproces
2007-04-09Smith & Nephew, Inc Endoscopy DivisionSeveral units were manufactured using a power supply that contains a 1 amp fuse where a 5 amp fuse is required. When the unit's power supply draws more that 1A, the fuse will fail

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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.