RecallHawk

FUJIFILM Healthcare Americas Corporation

36 FDA actions

Synapse PACS (7.6.0)

FUJIFILM Healthcare Americas Corporation

FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)

FUJIFILM Healthcare Americas Corporation

FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33

FUJIFILM Healthcare Americas Corporation

FUJIFILM Stiffening Wire Device (SW-2000)

FUJIFILM Healthcare Americas Corporation

ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynt

FUJIFILM Healthcare Americas Corporation

Synapse PACS (7.5)

FUJIFILM Healthcare Americas Corporation

Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200.

FUJIFILM Healthcare Americas Corporation

The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE)

FUJIFILM Healthcare Americas Corporation

Double Balloon Endoscope EN-840T, Over-tube TS-1214C

FUJIFILM Healthcare Americas Corporation

FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, che

FUJIFILM Healthcare Americas Corporation

Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24

FUJIFILM Healthcare Americas Corporation

APERTO Lucent MRI System

FUJIFILM Healthcare Americas Corporation

ECHELON Synergy V10.0

FUJIFILM Healthcare Americas Corporation

FCT iSTREAM Phase 1

FUJIFILM Healthcare Americas Corporation

Synapse PACS - Version 7.2.100

FUJIFILM Healthcare Americas Corporation

Synapse PACS - Version 7.1.000

FUJIFILM Healthcare Americas Corporation

Synapse PACS - Version 7.2.000

FUJIFILM Healthcare Americas Corporation

Synapse PACS - Version 7.1.000US

FUJIFILM Healthcare Americas Corporation

Synapse PACS - Version 7.3.000

FUJIFILM Healthcare Americas Corporation

Synapse PACS - Version 7.2.200

FUJIFILM Healthcare Americas Corporation

Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the proces

FUJIFILM Healthcare Americas Corporation

Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.

FUJIFILM Healthcare Americas Corporation

FUJIFILM Endoscope Model EB-710XT

FUJIFILM Healthcare Americas Corporation

Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)

FUJIFILM Healthcare Americas Corporation

ARIETTA x10

FUJIFILM Healthcare Americas Corporation

Scenaria View 4.2

FUJIFILM Healthcare Americas Corporation

Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)

FUJIFILM Healthcare Americas Corporation

Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)

FUJIFILM Healthcare Americas Corporation

FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for g

FUJIFILM Healthcare Americas Corporation

Surpria 64: Software Version V3.11, V3.22

FUJIFILM Healthcare Americas Corporation

SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C

FUJIFILM Healthcare Americas Corporation

Surpria: Software Version V3.11, V3.22

FUJIFILM Healthcare Americas Corporation

Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3

FujiFilm Healthcare Americas Corporation

Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3

FujiFilm Healthcare Americas Corporation

Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3

FujiFilm Healthcare Americas Corporation

Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0

FujiFilm Healthcare Americas Corporation