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Gimmi

Gimmi GmbH · Model S.2004.00 USB · UDI-DI 04049047669692

FWF Prescription
10
510(k) clearances
288
Adverse events
2
Recalls
50
Facilities

Description

ALPHANOVOCAM 4K UHD USB CAMERA SYSTEM INCL. CAMERA HEAD 4K 2160P

Recalls

DateFirmReason
2007-01-19Smith & Nephew, Inc Endoscopy DivisionSurgical camera control units were not designed and manufactured to pass the IEC 60101 testing for electrical fast transients (EFT)
2007-01-19Smith & Nephew, Inc Endoscopy DivisionSurgical camera control units were not designed and manufactured to pass the IEC 60101 testing for electrical fast transients (EFT)

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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.