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February 2025 Medical Device Recall Information (Japan) | NES

In Japan, when a medical device recall occurs, there is an obligation to immediately publicize it.

The PMDA (Pharmaceuticals and Medical Devices Agency), an agency affiliated with the MHLW (Ministry of Health, Labor and Welfare), is in charge of public announcements.




New Arrivals List

Ashtity MRI
Include-type heart pacemaker
Abbott Medical Japan LLC
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=1-2358
NES Medical Database [1-2358]

Low pressure boiling type washing machine RR-50 type
Equipment decontamination cleaning machine
Miura Industry Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=2-12183
NES Medical Database [2-12183]

Dexcom G6 CGM System
Glucose monitoring system
Corbridge Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=2-12184
NES Medical Database [2-12184]

Bright Chip Guidance Catheter
Intravascular catheter for central circulatory guidance
Cordis Japan LLC
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=2-12186
NES Medical Database [2-12186]

DLP Cannula for Heart muscle protection solution injection
Aortic cannula
Japan Medtronic Corporation
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=2-12187
NES Medical Database [2-12187]

Leica CM1950
Criostatothic tom
Leica Microsystems Co., Ltd. Toa DKK Co., Ltd. Annexed Office Building
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=2-12188
NES Medical Database [2-12188]

Biometric monitoring IntelliVue
Multi-item monitor with important parameters
Philips Japan Inc.
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=2-12195
NES Medical Database [2-12195]

Gyro Scan Intera 1.5T
Superconducting magnet type MR device for whole body
Philips Japan Inc.
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=2-12196
NES Medical Database [2-12196]

Intera Achaeva 1.5T
Superconducting magnet type MR device for whole body
Philips Japan Inc.
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=2-12197
NES Medical Database [2-12197]

Ingenuity TF PET/MR equipment
Positron CT system for nuclear medicine diagnosis
Philips Japan Inc.
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=2-12197
NES Medical Database [2-12197]

General-purpose diagnostic equipment Workstation program Synthetic CT
General-purpose diagnostic equipment program for workstations
Siemens Healthcare Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=2-12198
NES Medical Database [2-12198]

Lung Nodule Detection Program syngo.CT Lung CAD
X-ray diagnostic equipment program for workstations
Siemens Healthcare Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=2-12198
NES Medical Database [2-12198]

Diode laser for long-term wear depletion Medium-star monolith
Diode laser
Gunze Medical Co., Ltd. Tokyo Branch
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=2-12199
NES Medical Database [2-12199]

TS7000dV Operating Table System
Operating table system
Hillom Japan Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=2-12200
NES Medical Database [2-12200]

Elp-Bed Mess
Single use female blade
Akiyama Manufacturing Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=2-12201
NES Medical Database [2-12201]

NIM TriVantage EMG Tube
Electrode electromyograph
Japan Medtronic Corporation
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=2-12204
NES Medical Database [2-12204]

OrthoPilot Elite Navigation System
Surgical Navigation Unit
B.K. Browne Scrap Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=2-12206
NES Medical Database [2-12206]

Polypop swab & activated transport medium set (PPQB-AB)
Medically succulent twilight
Aoishi Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=2-12207
NES Medical Database [2-12207]

Triccupate Keep
Catheter catheter for bronchial suction
Demar Medical Japan Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=2-12208
NES Medical Database [2-12208]

Viewer Software Kada-View
General-purpose diagnostic equipment program for workstations
Photolon Medical Imaging Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=2-12211
NES Medical Database [2-12211]

COR Targeting System
Single-use bone surgery instrument
Johnson & Johnson Corporation
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=2-12213
NES Medical Database [2-12213]

Speed Low Temperature Sterilization System ES-H1600
Hydrogen peroxide gas sterilizer
Canon Medtec Supply Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=2-12217
NES Medical Database [2-12217]

FUJIFILM DR-XD 1000
Mobile digital general-purpose integrated X-ray diagnostic device
FUJIFILM Corporation
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=2-12218
NES Medical Database [2-12218]

Magnetic Resonance Tomography Opima MR360/Brivo MR355
Superconducting magnet type MR device for whole body
GE Healthcare Japan Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=2-12219
NES Medical Database [2-12219]

EGIS biliary stent
Bile duct stent
SB Kawasumi Corporation
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=2-12220
NES Medical Database [2-12220]

Lighttech DP1
Pulse Oximeter
Daikin Industries, Ltd. Special Operations Division
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=3-2964
NES Medical Database [3-2964]

Hakko Adapter
Infusion accessories set
Yakko Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=3-2965
NES Medical Database [3-2965]

Hakko Adapter
Infusion accessories set
Yakko Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=3-2966
NES Medical Database [3-2966]

Alexis, Wound Protector / Retractor
Single-use open-sourced detector
Applied Medical Japan Corporation
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=3-2967
NES Medical Database [3-2967]

Dialysis solution for multiple people TC-R
Dialysis solution supply system for multiple people
Toray Medical Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=3-2969
NES Medical Database [3-2969]

Multi-purpose personal dialysis machine TR-7700S
Multi-purpose dialysis machine
Toray Medical Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=3-2969
NES Medical Database [3-2969]

Endoscopic diagnostic imaging support software gastroAI-model G
Endoscopic diagnostic imaging support program for lesion detection
AI Medical Services Co., Ltd.
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=3-2970
NES Medical Database [3-2970]

Miller Bone Cement Accessories
Manual Orthopedic Injector
Zimmer Biomett LLC
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=3-2971
NES Medical Database [3-2971]

ROSA One Robotic System
Surgical Robotic Surgical Unit
Zimmer Biomett LLC
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=3-2971
NES Medical Database [3-2971]

Ashi CAD/CAM Titanium
Titanium alloy for dental non-casting
Pikache Inc
https://www.info.pmda.go.jp/rgo/MainServlet? recallno=3-2972
NES Medical Database [3-2972]




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