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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then installed this may lead to an error preventing user access to the dispensing software application, which may lead to delay in access to medications/supplies, and delivery/replenishment of patient specific orders; which may lead to delay in patient care.
Antivirus software was not consistently installed on impacted devices during the implementation process.
Unreleased software versions were installed on distributed devices without verification or validation.
Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as valid measurements by LIS.
U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet.
Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
Unreleased software versions were installed on distributed devices without verification or validation.
Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately lead to misdiagnosis of seizure location in neonates monitored with this device.
Unreleased software versions were installed on distributed devices without verification or validation.
Unreleased software versions were installed on distributed devices without verification or validation.
The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market notification (510(k)/de novo), so there is potential risk that the colony count and/or morphology information from images may not accurately reflect actual plate and may lead to inaccurate counts and/or morphology characteristics impacting patient diagnosis and subsequent care.
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.
There is a potential for improper crimps on the signal wires of the actuators which could result in a loss of ability to lower the bed or the foot section of the bed.
Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed, compared to those TJF duodenoscopes where manual cleaning began within one hour after patient procedure.
A bug in the 2.7.0 version of the G7 iOS App can cause the app to enter a state where it stops updating the estimated glucose value (EGV) and continues to show this stale EGV. If the user is unaware that the EGVs are not being updated and that glucose alerts will not trigger, there is potential for the missed detection of a hyperglycemic or hypoglycemic event or a treatment decision made based off incorrect data. There is no impact to transmitter communication with concurrently connected displays. A concurrently connected receiver, Apple Watch, and/or insulin pump will continue to receive EGVs directly from the transmitter when the app is in the problematic state. There is no impact to Automated Insulin Dosing (AID) therapy as the AID system continues to receive EGVs directly from the transmitter.
All RAM SAFE-T-FILL Micro Capillary Blood Collection tubes manufactured between July 31, 2023 to February 28, 2025 cause false positive results when used with Magellan Diagnostics LeadCare Testing Systems. False positive lead results may cause delayed results and additional unnecessary testing.
Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing (cross-contamination) between the wells of testosterone reagent packs lot 538081, which could potentially result in up to a 34% increase or a 23% decrease in patient results.