Maquet Cardiovascular Us Sales, Llc - Maquet Compressor Mini - Class 2 Recall
Compressor Mini To provide a supply of dry, filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meet the specifications of the compressor mini. compressor mini is intended to be operated by healthcare providers, physicians, nurses, and technicians. Compressor mini is to be used only for bedside application within the hospital environment. Compressor mini is neither intended nor suitable for use during in-hospital patient transportation or during ambulance or air transportation. Compressor mini is not suitable for use with MRI. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 29, 2014 Category: Medical Equipment Source Type: alerts
Ge Healthcare It - Imagecast PACS - Class 2 Recall
Imagecast PACS 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 and interpretations. Mammongraphic may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel res...
Source: Medical Device Recalls - January 16, 2014 Category: Medical Equipment Source Type: alerts
Ge Healthcare It - GE Centricity PACS (Versions 3.1.1.2 or later) - Class 2 Recall
Centricity PACS System versions 3.X and higher and 4.X and higher Product Usage: 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 - January 15, 2014 Category: Medical Equipment Source Type: alerts
Wexford Labs Inc - Ready To Use ThymoCide - Class 2 Recall
Ready to Use Thymo-Cide, Germicidal Detergent, containing 0.051% thymol, packaged in 1-qt. bottles. The firm name on the label is Wexford Labs, Inc., Kirkwood, MO. For disinfection of hard, non-porous surfaces (floors, walls, tables, etc.) in operating rooms, intensive care, nurseries, emergency areas, dental operatories, police, EMS, and all health care facilities. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 20, 2013 Category: Medical Equipment Source Type: alerts
GE Healthcare It - Centricity Perinatal and Centricity Intensive Care - Class 2 Recall
Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare delivery systems such as a Labor and Delivery, Postpartum Maternal Care, newborn Nursery, critical care units including Neonatal Intensive Care Units (NICU), and may also be used in physicians offices and outpatient clinics. This product is primarily intended to serve the purpose of electronic documentation of clinical data and is designed to accept, transfer, display, calculate, store and manage clinical data. System capabilities provide the user with the ability to acquire data from the medical devices and to docu...
Source: Medical Device Recalls - November 19, 2013 Category: Medical Equipment Source Type: alerts
Philips Healthcare Informatics, Inc. - IntelliSpace PACS - Class 2 Recall
Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare Informatics, Inc. Foster City, CA IntelliSpace PACS are image management systems intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, pro...
Source: Medical Device Recalls - November 14, 2013 Category: Medical Equipment Source Type: alerts
Ge Healthcare It - GE Centricity PACSIW - Class 2 Recall
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives 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. Lossy compressed mammographic images and digitized film screen images may only be interpreted using an FDA approved monitor that offers at least 5 M pixel resolution and meets other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited t...
Source: Medical Device Recalls - October 31, 2013 Category: Medical Equipment Source Type: alerts
GE Healthcare It - GE Centricity PACS - 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 - October 31, 2013 Category: Medical Equipment Source Type: alerts
GE Healthcare It - Centricity Cardio Imaging - Class 2 Recall
Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a software only device to operate on general purpose computing hardware. Centricity Cardio Imaging receives medical images and other information from various data sources. Information can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Centricity Cardio Imaging is intended to assist trained professionals in the viewing, analysis and diagnostic interpretation of images and other information for the diagnosis and t...
Source: Medical Device Recalls - October 22, 2013 Category: Medical Equipment Source Type: alerts
Rauland-Borg Corp - Responder 5 - Class 2 Recall
Responder 5 is a nurse call communication system that connects patients with staff in a hospital. The nurse call system also connects team members and departments from radiology, physical therapy, transport, environmental services and more. Responder 5 is used in hospitals and long term patient care facilities to allow for remote communications between patients and patient monitoring devices and healthcare providers (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 18, 2013 Category: Medical Equipment Source Type: alerts
Respironics California Inc - V60 Ventilator - Class 1 Recall
Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008) 1053613 (989805628251) 1053614 (989805612101) 1053615 (989805613391) 1053616 (989805613661) 1053617 (989805611761) 1053618 (n/a) R1053618 (n/a) 1076709 (n/a) 1076715 (989805627411) 1076716 (989805627431) 1076717 (989805627441) DU1053617 (989805616411) U1053614 (989805636441) U1053617 (989805636631) Power Mgmt. Board, Respironics Material P/N: 1054358, Philips 12 Digit P/N: 4536561512581. The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for sp...
Source: Medical Device Recalls - June 18, 2013 Category: Medical Equipment Source Type: alerts
Stryker Medical Division of Stryker Corporation - Medical Surgical Bed, Model 3005S3EX - Class 2 Recall
Medical Surgical Bed, Model 3005S3EX Medical Surgical Bed The S3" MedSurg Bed, Model 3005 is intended to support and transport patients within the Med/Surg and Critical Care hospital environments. The bed is typically used in pre-op, post-op and recovery areas of hospital facilities. The intended user for this product is both Health Care Providers (HCPs: nurses, nurses aides, and medical doctors) and human patients. Lockout features may limit patient accessible controls. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 4, 2013 Category: Medical Equipment Source Type: alerts
Stryker Medical Division of Stryker Corporation - Medical Surgical Bed, Model 3002SEX - Class 2 Recall
Medical Surgical Bed, Model 3002SEX Medical Surgical Bed The S3" MedSurg Bed, is intended to support and transport patients within the Med/Surg and Critical Care hospital environments. The bed is typically used in pre-op, post-op and recovery areas of hospital facilities. The intended user for this product is both Health Care Providers (HCPs: nurses, nurses aides, and medical doctors) and human patients. Lockout features may limit patient accessible controls (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 4, 2013 Category: Medical Equipment Source Type: alerts
