Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,693–1,704 of 2,908 recalls
A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly.…
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.
Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy.…
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use.…
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use.…
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use.…
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use.…
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals exceeded residual limits, which may lead to a possible loss or lack of functionality that…
Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus necessitating use of an alternate form of ventilation, or…