The manufacturer received complaints that customers were attempting to install the fitting software using the supplied USB drive, an error message was received, and installation failed. The failed installation has not impact to the current version of the software, and users are able to continue programming devices with the current software version.
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Implants & Prosthetics
ðĨ Medical Devices âĒ 4,589 recalls
Class I - Dangerous
Potential increase in fracture rate was detected during internal testing, in addition to potential discoloration inside the inner pouch of the packaging.
These Truliant Splined Stem Extension, 18mm x 120mm were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 17mm x 80mm when the implant size is 18mm x 120mm.
Class I - Dangerous
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Class I - Dangerous
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Class I - Dangerous
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Class I - Dangerous
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Class I - Dangerous
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Class I - Dangerous
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Class I - Dangerous
Power supply (Model Number: TLC-2003) ME90A2403F01 (24 VDC, 3.75 A, 90 W, 1% peak to peak ripple and noise, which meets UL/EN/IEC-60601-1-2, 4th edition specification) shipped versus Power supply (Model Number: TLC-2003) MENB1100A2403F01 (24 VDC, 4.2 A, 101 W, 1% peak to peak ripple and noise, which meets UL/EN/IEC-60601-1-2, 3rd edition specification)
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Class I - Dangerous
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Class I - Dangerous
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Class I - Dangerous
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
Advanced Bionics
Class I - Dangerous
Three materials used in the makeup of the implant were mistakenly left off the list of bio-compatible materials in the firm's previously approved submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan.
Class I - Dangerous
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.