Medical equipment, implants, and diagnostic devices
Maquet Critical Care AB
Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.
Philips Ultrasound
Ultrasound transducer devices were refurbished beyond their useful life.
MEDLINE INDUSTRIES, LP - Northfield
Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.
Ortho-Clinical Diagnostics
A software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.
Multiple plate failures documented as a result of the Low Positive Template Control being too high and out of range using the affected lot of ColoSense Test Kit.
Philips Ultrasound
Ultrasound transducer devices were refurbished beyond their useful life.
Siemens Healthcare Diagnostics
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
Becton Dickinson Infusion Therapy Systems
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Becton Dickinson Infusion Therapy Systems
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
GE Medical Systems China Co.
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.
Philips North America
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.
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Becton Dickinson Infusion Therapy Systems
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Becton Dickinson &
BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates.
MEDLINE INDUSTRIES, LP - Northfield
There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.
Becton Dickinson Infusion Therapy Systems
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Terumo Cardiovascular Systems
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.