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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Firm has received reports of patient burns in surgical procedures where device was used.
There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
Firm has received reports of patient burns in surgical procedures where device was used.
Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve diagnostic exposures due to variations in hardware and how different timers are started.
Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
The test medium may not perform as intended.
Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications.
Electrical issues that could potentially render the device non-functional, give off electromagnetic influence to surrounding equipment, and risk of burns when in use.
Service life of the electrical seat part drive of the treatment chair may be shortened unexpectedly after several years of use due to a potential wear-related reduction in the self-locking of the drive and may remain undetected. A worsened self-locking of the seat drive can lead to overriding the drive s end position when positioning the patient with the seat part in an inclined position
Weld protrusion/physical gap between the housing and pack cover, may exceed design specification, due to a manufacturing issue, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema.
Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.
There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during daily maintenance; 2) Sample Laboratory Report error; 3) Customer requests mechanism to prevent user error when creating new lots of value assigned Calibrators; 4) Error in processing tests after CCCintController encountered an error with the assay information downloaded from SCC; 5) The assay editor does not correctly check sample dilution total volume limits; 6) User-Applied Labels not adhering to Reagent Bottles; 7) ICT Module did not expire after warranty was exceeded. These performance issues could lead to erroneous results for multiple analytes.
Medical device components were marketed without FDA clearance
Medical device components were marketed without FDA clearance
Medical device components were marketed without FDA clearance and without FDA approval
Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.