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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.
When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added to the acquisition.
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Complaints have been received concerning the humeral stem failing to mate with the broach handles for a shoulder device. This could result in delay of procedure or revision surgery.
Potential patient exposure to the graphite substrate.
Product label intended for the European community was distributed to the USA market via their US distribution organization
The firm identified a precipitation issue which may cause late Ct reactors (a false positive result) with a rate of 5 to 10% for affected vials of RNA Master Mix.
There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the water system of heater-cooler devices which could result in contaminated water potentially aerosolized into the operating room during surgery which could result in patient infection.
Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
Software anomalies that may lead to the generation of erroneous results.
Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device