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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Top label of the outer package of the collection kit Item 5820-3118 showed expiration date of 2022/05/01 (correct expiration date) while side label showed expiration date of 2021/05/01 (incorrect expiration date)
The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. If quality controls are not performed or do not pass for each vial of reagent, there is a potential risk of reporting an erroneous result.
Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.
Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions may occur if an affected product is used.
The processing of collected episode data may fail due to a software error.
Product is labeled as non-pyrogenic but endotoxin testing was not performed.
Warning Added: Using damaged cables or chargers, or charging when moisture is present, can cause fire, electric shock, injury, or damage to Speech Generating Device or other property
Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades
Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades
Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades
Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades
The Aptio Automation Firmware for the ADVIA Centaur XP/XPT Interface Module may lead, in some cases, to an incorrect association of test results to sample ID. Incorrect association of test results could impact clinical interpretations and clinical decisions.
System operator manual states that the system should be rebooted once, every 7 days. In some cases, users are not following these instructions and the system is running for more than 7 days. Under rare circumstances, this may result in a partial freeze of the user interface which would no longer update the vital signs
Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments.
Product was released prior to all testing being completed. If used and a drive tube leak were to occur, may cause illness or injury.
Due to a higher rate of false positive test results.
There is a potential for distal tip dislodgement or separation.
There is a potential for distal tip dislodgement or separation.
There is a potential for distal tip dislodgement or separation.
There is a potential for distal tip dislodgement or separation.