Angiodynamics Inc. (Navilyst Medical Inc.) - Peripherally Inserted Central Catheters (PICC) - Class 2 Recall
Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The Xcela Power Injectable PICC is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 6, 2016 Category: Medical Equipment Source Type: alerts
Angiodynamics Inc. (Navilyst Medical Inc.) - Peripherally Inserted Central Catheters (PICC) - Class 2 Recall
BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit - UPN # H965750191/Catalog No:75-019 The BioFlo PICCs with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 6, 2016 Category: Medical Equipment Source Type: alerts
Novarad Corporation - NovaPACS - Class 2 Recall
NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation. Picture archiving and communication system (PACS) Product Usage NovaPACS is a picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. NovaPACS uses a variety of workstations, including a Technologist Workstation, Enterprise Radiologist Workstation, Cardio Viewer and Workstation, NovaMG Workstation, and NovaWeb Web Viewer. The NovaPACS software makes images and data available in digital format from all common modalities. The images are viewed on a compute...
Source: Medical Device Recalls - August 26, 2016 Category: Medical Equipment Source Type: alerts
GE Healthcare It - GE Centricity PACS Workstation - Class 2 Recall
GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System Used as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. Also used 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 - August 18, 2016 Category: Medical Equipment Source Type: alerts
Hill-Rom, Inc. - Volker 2080, 2082, S 280 and S 282 - Class 2 Recall
Volker 2080, 2082, S 280 and S 282 series beds with lateral release button. A/C Powered Adjustable Hospital Bed Product Usage: Volker model 2080/3010/3080 nursing beds are intended for the care of residents in rooms in nursing homes, in residential homes for the elderly and in suitable rooms in private residences. They may not, however, be used for transportation purposes. Any deviation from this use is expressly excluded from possible liability claims. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 10, 2016 Category: Medical Equipment Source Type: alerts
Draeger Medical, Inc. - Babytherm 8004/8010 - Class 2 Recall
Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004), non sterile, software controlled. Product Usage: Babytherm 8004/8010 is an open care infant warmer system for warming premature babies, neonates and infants with a body weight of up to 8 kg (17.6 lbs). The device is intended for use in delivery rooms, operating rooms, maternity and obstetric units, neonatal and pediatric wards, neonatal and pediatric intensive care units. Therapy and nursing uses: - As a resuscitation table and in birthing rooms, obstetric units, and NICUs - As infant warmer...
Source: Medical Device Recalls - July 29, 2016 Category: Medical Equipment Source Type: alerts
Ge Healthcare It - Imagecast PACS 3.5 and 3.6 - Class 2 Recall
Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may o...
Source: Medical Device Recalls - July 29, 2016 Category: Medical Equipment Source Type: alerts
Hospira Inc. - LifeCare PCA Plus II - Class 2 Recall
The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients through the intravenous or epidural routes in a wide range of clinical settings, including ICU, CCU, SICU, trauma units, bone marrow transplant centers, burn units, oncology centers, and medical/surgical nursing units. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 9, 2016 Category: Medical Equipment Source Type: alerts
Navilyst Medical, Inc., an AngioDyamics Company - BioFlo PICC with ENDEXO and PASV Valve Technology, Maximal Barrier Nursing Kit - Class 2 Recall
BioFlo PICC with ENDEXO and PASV Valve Technology, Maximal Barrier Nursing Kit, UPN H965750211 The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 15, 2016 Category: Medical Equipment Source Type: alerts
Ascom US, INC. - Ascom Mobile Monitoring Gateway - Class 2 Recall
Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0). (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 11, 2016 Category: Medical Equipment Source Type: alerts
Arjo, Inc. dba ArjoHuntleigh - ArjoHuntleigh Inc. - Class 2 Recall
The Concerto Basic Shower Trolley is intended for assisted hygiene care, especially showering and bathing of residents in care environments such as senior/assisted living, group home, special care, nursing homes, hospitals and home care. The Concerto Basic Shower Trolley is intended for indoor use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 15, 2016 Category: Medical Equipment Source Type: alerts
Hospira Inc. - Hospira Inc. a Pfizer company - Class 2 Recall
The Symbiq infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. It is intended primarily for use in the hospital setting and can be used in other acute and non-acute areas, such as, but not limited to, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion, Centers, Hospice, Sub acute facilities, Outpatient/Surgical Centers, Long-term Care, Urgent Care, Transport, and Physician Offices. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 24, 2016 Category: Medical Equipment Source Type: alerts
Philips Electronics North America Corporation - Allura CV20 - Class 2 Recall
Allura CV20; Model Number: 722031 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab technicians), who are qualified to perform medical procedures on humans (having a maximum weight of 250 kg.) with probable internal diseases or injuries for: " Dedicated vascular and carotid imaging applications, including diagnostic and interventional procedures. " Cardiac imaging applications including diagnostics, interventional rocedures, pacemaker implantations and electrophysiology (EP). " Non-vascular interventions such as draina...
Source: Medical Device Recalls - January 31, 2016 Category: Medical Equipment Source Type: alerts
Philips Electronics North America Corporation - Cardiovascular Allura Centron - Class 2 Recall
Cardiovascular Allura Centron; Model Number: 722400 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab technicians), who are qualified to perform medical procedures on humans (having a maximum weight of 250 kg.) with probable internal diseases or injuries for: " Dedicated vascular and carotid imaging applications, including diagnostic and interventional procedures. " Cardiac imaging applications including diagnostics, interventional rocedures, pacemaker implantations and electrophysiology (EP). " Non-vascular intervent...
Source: Medical Device Recalls - January 31, 2016 Category: Medical Equipment Source Type: alerts
GE Healthcare - GE Healthcare Centricity Universal Viewer Version - Class 2 Recall
The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 6, 2015 Category: Medical Equipment Source Type: alerts
