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Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography

FDA Recall
Open, Classified ·GE Medical Systems, LLC·Product code MUE·October 24, 2025

GE Healthcare Innova X-ray Imaging Systems. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. This device is not intended for mammography applications.

FDA Recall
Terminated ·GE Healthcare, LLC·Product code IZI·May 4, 2011

BD Bactec Blood Culture Procedural Tray, Cat. Number 442805 Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 Used in conjunction with the blood collection system.

FDA Recall
Terminated ·Becton Dickinson & Company·Product code JGE·April 22, 2011

Turbidimetric Method, Globulin

FDA classification
FDA Class 1 ·Turbidimetric Method, Globulin

S. JEE ENTERPRISES

Manufacturer
🇵🇰 Pakistan·1 Importer

Actif Age Lda

Manufacturer
🇵🇹 Portugal·1 Basic UDI-DI·2 Devices

AGEING TECH SRL

Manufacturer
🇮🇹 Italy·1 Basic UDI-DI·1 Device·BUREAU VERITAS ITALIA S.P.A.

Age Solutions Srl

Manufacturer
🇮🇹 Italy·TUV Rheinland Italia SRL

NEW AGE ITALIA S.R.L.

Manufacturer
🇮🇹 Italy·1 Basic UDI-DI·1 Device·MTIC InterCert S.r.l.

Daud Jee Mfg. Co

Manufacturer
🇵🇰 Pakistan·9 Basic UDI-DIs·646 Devices·6 Importers

(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.

FDA Enforcement
Class II ·Ongoing·GE Healthcare, LLC·August 31, 2022

(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.

FDA Recall
Open, Classified ·GE Healthcare, LLC·Product code LLZ·July 15, 2022

MADA MEDICAL PRODUCTS, INC.

FDA UDI
MADA MEDICAL PRODUCTS, INC·00815160020832·A device that is connected to an independent su...

CableAGE

FDA UDI
CAMBRIDGE INTERVENTIONAL LLC·00811746030783·Cable Adapter

DAUD JEE MFG CO

FDA registration
DAUD JEE MFG CO·36 products·🇵🇰 Pakistan

Digital Age Dental Laboratories, Ltd.

FDA registration
Digital Age Dental Laboratories, Ltd.·13 products·🇻🇳 Vietnam

Hillal Biyoteknoloji Biyomühendislik Sanayi ve Ticaret Anonim Şirketi Ege Serbest Bölgesi Şubesi

Manufacturer
🇹🇷 Türkiye

C6-2GE Ultrasonic Transducer(FDA)

FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904088310·

JIE GAO PLASTIC PRODUCTS CO., LTD.

FDA registration
JIE GAO PLASTIC PRODUCTS CO., LTD.·11 products·🇨🇳 China

SHENZHEN JIE BISHI TECHNOLOGY CO., LTD

FDA registration
SHENZHEN JIE BISHI TECHNOLOGY CO., LTD·19 products·🇨🇳 China