IWZ - BEUDAMED

Curix Opthos H, size 35x43 cm A radiographic medical x-ray film designed to optimize diagnostic chest imaging by providing complete diagnostic information including superbly visualized lung detail along with a high level of retro-cardiac, sub-diaphragmatic and mediastinal information.

FDA Recall

Terminated ·AGFA Corp.·Product code IWZ·October 4, 2011

DVB KODAK DRYVIEW --- 35x43 cm --- 125 SHT --- REF 8723132 --- Made in U.S.A. by Carestream Health, Inc., 150 Verona St, Rochester, New York 14608. General purpose radiography.

FDA Recall

Terminated ·Carestream Health, Inc.·Product code IWZ·December 20, 2011

Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc.

FDA Recall

Terminated ·Carestream Health Inc.·Product code IWZ·July 2, 2014

KODAK T-MAT G/RA Film, Catalog/REF # 151 0023, 24x30 cm, 5-100 Sheet Boxes FOLHAS/Hojas, Made in U.S.A. by Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608 --- Device Listing # E420904 Intended use: Imaging film

FDA Recall

Terminated ·Carestream Health, Inc.·Product code IWZ·March 12, 2010

Mamoray HDR-C PLUS Mammography film

FDA Recall

Terminated ·AGFA Corp.·Product code IWZ·February 16, 2006

Drystar Mammo. Display of Mammographic images.

FDA Recall

Terminated ·AGFA Corp.·Product code IWZ·March 2, 2010

KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP21S, REF/Catalog Number 8118226 --- COMMON/USUAL NAME: Dental Intraoral Radiographic Film -- 20 cartons of 80 packets. Product Usage: Dental intraoral radiography

FDA Recall

Terminated ·Carestream Health, Inc.·Product code IWZ·January 17, 2013

Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12, Radiomat M+ NIF 25,4CM x 30,5CM

FDA Recall

Terminated ·AGFA Healthcare Corp.·Product code IWZ·October 24, 2014

PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD, XJM85, EKLYZ. Product Usage: Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the pinholes varies as material from this coating run shows pinholes in different frequencies and intensities.

FDA Recall

Terminated ·Agfa N.V. Septestraat 27 Mortsel Belgium·Product code IWZ·January 25, 2019

KODAK T-MAT L/RA Film, Catalog/REF # 181 4631, 35x43 cm 5-100 Sheet Boxes Folhas/Hojas, Made in U.S.A. by Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608 --- Device Listing # E420904 Intended use: Imaging film

FDA Recall

Terminated ·Carestream Health, Inc.·Product code IWZ·March 12, 2010

Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF Product Usage: Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides of the film, with a radiotransparent material coated on one or both sides of the film, with a photographic emulsion intended to record images during diagnostic radiologic procedures.

FDA Recall

Terminated ·AGFA Healthcare Corp.·Product code IWZ·July 16, 2014

INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.

FDA Recall

Terminated ·Carestream Health Inc.·Product code IWZ·July 2, 2014

Konica Minolta Duplicating Film Emulsions. Konica Medical Film. Emulsion numbers X(=any number), X 742, X842, X152. Film type SR-DUP 8x10, 10x12, 11x14, and 14x17. Film type PPD DUP 10x12 only and Emulsion Number X152. SR-DUP C 14x17 Emulsion X023 only.

FDA Recall

Terminated ·Konica Medical Imaging, Inc.·Product code IWZ·October 9, 2003

Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.

FDA Recall

Open, Classified ·Roche Diagnostics Operations, Inc.·Product code MMI·April 7, 2021

Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.

FDA Recall

Open, Classified ·Roche Diagnostics Operations, Inc.·Product code MMI·April 7, 2021

Xoran MiniCAT CT Scanner ID ENT00001

FDA Recall

Terminated ·Xoran Technologies, Inc.·Product code JAK·December 14, 2009

GE Centricity PACS-IW software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The intended use:The Centricity PACS-IW is used to receive medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.

FDA Recall

Terminated ·Ge Healthcare It·Product code LLZ·February 18, 2010

GE Centricity Web Diagnostic 1.0(WebDX) software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Intended use:The Centricity PACS-IW is used to receive medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.

FDA Recall

Terminated ·Ge Healthcare It·Product code LLZ·February 18, 2010

Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument specific reagents and flow cells (MiSeqDx Universal Kit 1.0), imaging hardware, and data analysis software. The MiSeqDx Platform is intended for targeted sequencing of human genomic DNA from peripheral whole blood samples.

FDA Recall

Terminated ·Illumina Inc·Product code PFF·July 28, 2014

Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy

FDA Recall

Open, Classified ·Percussionaire Corporation·Product code NHJ·September 16, 2024