ED-3490TK Video Duodenoscope by Pentax: FDA Safety Communication – UPDATE

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UPDATE: Importance of Following Validated Reprocessing Instructions for PENTAX ED-3490TK Video Duodenoscopes: FDA Safety Communication

Date Updated: January 17, 2017 Audience: Users of the PENTAX Medical (PENTAX) ED-3490TK Video Duodenoscope and reprocessing facilities including: Gastroenterologists Gastrointestinal surgeons Endoscopy nurses Staff working in endoscopy reprocessing units in health care facilities Infection control practitioners Facility risk managers Medical Specialties: Gastroenterology, Infection Control Device: PENTAX ED-3490TK Video Duodenoscope Summary of Problem and Scope:…

Lifepak 1000 Defibrillators by Physio-Control: Voluntary Field Action

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Duodenoscopes by Fujifilm Medical Systems: Safety Communication

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Emergency Use Authorization Amendment: Letter Granting EUA Amendment(s) for the Trioplex Real-time RT-PCR (CDC)

On February 26, 2016, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Centers for Disease Control and Prevention’s (CDC) Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA) for the presumptive detection of Zika virus-specific IgM in human sera or cerebrospinal fluid (CSF) that is submitted alongside…

FUJIFILM Medical Systems, U.S.A., Inc. removes certain older duodenoscope models from clinical use: FDA Safety Communication

Date Issued: January 13, 2017 Audience: Users and reprocessors of the FUJIFILM Medical Systems, U.S.A., Inc. (Fuji) ED-530XT duodenoscope, as well as users of Fuji’s ED-250XL5, ED-250XT5, ED-450XL5 and ED-450XT5 duodenoscopes including: Gastroenterologists Gastrointestinal surgeons Endoscopy nurses Staff working in endoscopy reprocessing units in health care facilities Infection control practitioners Facility risk managers Medical Specialties:…

PNC-27 Products: FDA Warning – Do Not Use For Treatment or Cure for Cancer

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Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions – Guidance for Investigational Device Exemption Sponsors, Sponsor

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Meeting Notice: March 17, 2017 Joint Meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee and the Risk Communication Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-0001] Joint Meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee and the Risk Communication Advisory Committee; Notice of Meeting AGENCY:  Food and Drug Administration, HHS. ACTION:  Notice. SUMMARY:  The Food and Drug Administration (FDA) announces a forthcoming public advisory…