O-arm O2 Imaging System. Mobile X-Ray System.
Medtronic Navigation, Inc.-Boxborough
Class I - Dangerous
A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
ðĨ
Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
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 the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised.
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
Product packaging contains the wrong part number and kit contents.
Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised.
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.
REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.
Becton, Dickinson and Company, BD Bio Sciences
Class I - Dangerous
Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.
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.
Servo-u Ventilator System. Model Number: 6688600.
Maquet Critical Care AB
Class I - Dangerous
Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.
Class I - Dangerous
Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches.