Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.
🏨
Other Medical Devices
🏥 Medical Devices • 15,809 recalls
VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Device approved and commercialized in Japan only.
Boston Scientific
Class I - Dangerous
Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.
Class I - Dangerous
Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.
Class I - Dangerous
The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury from a patient fall as the false latched component may initially bear weight but can loosen from the Q-link resulting in a detachment and drop.
Class I - Dangerous
Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.
Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Class I - Dangerous
Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in life-threatening injury.
The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury from a patient fall as the false latched component may initially bear weight but can loosen from the Q-link resulting in a detachment and drop.
Class I - Dangerous
Due to manufacturing error, digital analog rotational feature is 180 degrees off.
Class I - Dangerous
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Class I - Dangerous
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Class I - Dangerous
Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.
Class I - Dangerous
Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.
Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Class I - Dangerous
Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in life-threatening injury.
Class I - Dangerous
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Philips eL18-4 EMT Transducer.
Philips Ultrasound
Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.
Philips C9-5EC Transducer.
Philips Ultrasound
Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.
Change Healthcare Cardiology Hemodynamics Software
CHANGE HEALTHCARE CANADA COMPANY
Class I - Dangerous
Due to complaints, software update may cause software to unexpectedly shutdown.
Philips eL18-4 Transducer.
Philips Ultrasound
Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.
Class I - Dangerous
Cather packaging may contain the incorrect French size.
Philips C5-2 Transducer.
Philips Ultrasound
Class I - Dangerous
Ultrasound transducer devices were refurbished beyond their useful life.