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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficient pacing support leading to cardiac arrest, syncope, or hospitalization; or system revision (explant/replacement) leading to infection, hematoma, or temporary impairment.
There were reports of an increase in reactive negative controls and false positive results.
There were reports of an increase in reactive negative controls and false positive results.
Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised.
Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte fluid to splash into the face of the user when attempting to open the peel seam to mix the two chambers prior to treatment.
Three issues 1. Label error: The manufacturer information in the labeling is not correct, the manufacturer's name is mislabeled as "Developed by AcoSound," Correct should be "Manufactured by Hangzhou AcoSound." And the labeling has no statement of the place of business for the manufacturer. 2. Customer information: The customer "Blaid" information is not correctly marked; Blaid is not the manufacturer. 3. UDI Information: The UDI information is incomplete and without DI information and correct Pl information, not complied with UDI label requirements.
Sterility assurance for Ophthalmic knives.
The MUSE Administrator Account active directory or local credential could potentially be used from your local network to log into a GE HealthCare MUSE 5 system and potentially manipulate recorded patient data.
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Software issue that could potentially lead to the device tipping over from Balance Mode.
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded.
A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.
Potential breach of sterile barrier packaging.
Potential breach of sterile barrier packaging.