Virtual Radiologic Corp. - vRad - Class 2 Recall
vRad PACS with Mammography (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 22, 2023 Category: Medical Devices Source Type: alerts
GE Medical Systems, LLC - Centricity Universal Viewer 6.0 - Class 2 Recall
Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imaging sources. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 17, 2022 Category: Medical Devices Source Type: alerts
GE Medical Systems, LLC - Centricity PACSIW with Universal Viewer - Class 2 Recall
Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and data from various imaging sources. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 17, 2022 Category: Medical Devices Source Type: alerts
Mckesson Medical-Surgical Inc. Corporate Office - IZI, MEDICAL Chemical - Class 3 Recall
Skin markers: a. IZI MEDICAL PRODUCTS LLC Multi-Modality Markers SKIN MARKER RADIO 1.5MM 50BX Catalog #MM3005. b. SKIN MARKER MAMMO BB2.0 100B - Mammography Skin Marker Catalog # SDM-BB20. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 27, 2022 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Centricity PACSIW with Universal Viewer - Class 2 Recall
Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 23, 2021 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - Centricity Universal Viewer, Centricity Universal Viewer 6.0 - Class 2 Recall
Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 23, 2021 Category: Medical Devices Source Type: alerts
Shanghai United Imaging Healthcare Co., Ltd. - Stationary xray system - Class 2 Recall
Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended to used by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. Not for mammography. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 3, 2021 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - MAMMOMAT Revelation - Class 2 Recall
MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 17, 2020 Category: Medical Devices Source Type: alerts
Eizo Corporation - RadiForce GX560 - Class 2 Recall
RadiForce GX560 monochrome LCD monitor, models 0FTD2347 and 0FTD2379 - Product Usage: is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 9, 2020 Category: Medical Devices Source Type: alerts
Eizo Corporation - RadiForce RX360 - Class 2 Recall
RadiForce RX360, model 0FTD2346 - Product Usage: is a color LCD monitor indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 9, 2020 Category: Medical Devices Source Type: alerts
Agfa N.V. - DR 800 with MUSICA Dynamic - Class 2 Recall
AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 - Product Usage: DR 800: Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures: positioning fluoroscopy procedures, gastro-intestinal examinations, urogenital tract examinations, and angiography. It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts. The DR 800 is not intended for mammography applications (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 4, 2020 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - Siemens AXIOM Aristos FX - Class 2 Recall
System AXIOM Aristos FX - Product Usage: A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, and excluding mammography. Radiographic exposures may be taken with the patient in sitting, standing, or supine positions. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 6, 2020 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - Siemens AXIOM Aristos FX Plus - Class 2 Recall
System AXIOM Aristos FX Plus - A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems; and allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, and extremities. It is not designed for mammography use. Radiographic exposures may be taken with the patient in the sitting, standing, or supine positions. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 6, 2020 Category: Medical Devices Source Type: alerts
Agfa N.V. - Agfa DR 800 - Class 2 Recall
AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not intended for mammography applications (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 19, 2020 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - Ysio Max - Class 2 Recall
Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures f the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio max system is not meant for mammography. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 21, 2020 Category: Medical Devices Source Type: alerts
