Siemens Medical Solutions USA, Inc. - Class 2 Recall
The Siemens Symbia T Series is a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images. Product Usage: Indications for use: The Siemens Symbia T series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer...
Source: Medical Device Recalls - August 21, 2015 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc. - ACUSON S Family ultrasound systems - Class 2 Recall
ACUSON S Family ultrasound systems utilizing the 18L6 HD and/or 6C1 HD biopsy guidelines 6C1HD - model numbers: 10442008 6C1HD Needle Guide, S3000; 10440586 6C1 HD Biopsy Guide, S2000 18L6 - model numbers: 10442007 18L6 Biopsy Guide, S3000 10044200 S2000 Biopsy Starter Kit, 18L6 HD 10855189 18L6 HD Biopsy Starter Kit, S1000 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular app...
Source: Medical Device Recalls - August 6, 2015 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc. - ACUSON S2000 and ACUSON S3000 ultrasound systems - Class 2 Recall
ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 31, 2015 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc. - ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems. - Class 2 Recall
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 30, 2015 Category: Medical Equipment Source Type: alerts
Volcano Corporation - Intravascular Ultrasound System - Class 2 Recall
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5i Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 21, 2015 Category: Medical Equipment Source Type: alerts
Volcano Corporation - Intravascular Ultrasound System - Class 2 Recall
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model CORE Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 21, 2015 Category: Medical Equipment Source Type: alerts
Volcano Corporation - Intravascular Ultrasound System - Class 2 Recall
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5ix/s5iz Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 21, 2015 Category: Medical Equipment Source Type: alerts
Volcano Corporation - Intravascular Ultrasound System - Class 2 Recall
Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 21, 2015 Category: Medical Equipment Source Type: alerts
Volcano Corporation - Intravascular Ultrasound System - Class 2 Recall
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5x. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 21, 2015 Category: Medical Equipment Source Type: alerts
Volcano Corporation - Intravascular Ultrasound System - Class 2 Recall
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model CORE Mobile. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 21, 2015 Category: Medical Equipment Source Type: alerts
Philips Medical Systems (Cleveland) Inc - Brilliance CT Big Bore Radiology - Class 2 Recall
Brilliance CT Big Bore Radiology (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 12, 2015 Category: Medical Equipment Source Type: alerts
Siemens Medical Solutions USA, Inc - syngo Workflow SLR - Class 2 Recall
syngo Workflow SLR; The information system syngo¿ Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration, examination, reporting, statistics and system administration. The system electronically displays stores, retrieves, transfers, exchanges, and prints. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 3, 2015 Category: Medical Equipment Source Type: alerts
Villa Radiology Systems LLC - Juno DFR Xray system - Class 2 Recall
Juno DFR X-ray system (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 7, 2015 Category: Medical Equipment Source Type: alerts
Villa Radiology Systems LLC - Juno DRF Xray system - Class 2 Recall
Juno DRF system (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 7, 2015 Category: Medical Equipment Source Type: alerts
GE Healthcare - GE Centricity PACS 3.2 - Class 2 Recall
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print and export images when connected with the Centricity PACS infrastructure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 27, 2015 Category: Medical Equipment Source Type: alerts
