All Recalls

92,900 total recalls in our database

🏥 Medical Devices Class I - Dangerous

GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the Whizz report. This could potentially lead to an incorrect clinical decision due to inaccuracy in the fetal size and growth calculation.

May 16, 2025 Diagnostic Equipment View Details →
🏥 Medical Devices Class I - Dangerous

Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT performance.

May 29, 2025 Other Medical Devices View Details →

Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.

May 28, 2025 Infusion Pumps View Details →

Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.

May 28, 2025 Infusion Pumps View Details →

Due to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature. Additionally, following changes in patient temperature without an in vivo recalibration, affected probes may experience inaccuracy in other measured parameters, including pCO2, pO2, pH, Potassium and calculated parameters, including BE, Bicarbonate, Arterial Oxygen Saturation, Delivered Oxygen, Area Under of the Curve of Delivered Oxygen, Oxygen Consumption, and Oxygen Extraction Ratio, which utilize temperature as an input. Inaccurate data may lead to inappropriate user response.

May 28, 2025 Other Medical Devices Nationwide View Details →