Medical Devices Recalls

Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as valid measurements by LIS.

Lack of sterility assurance.

Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality control (QC), and patient results for all assays except for sodium, potassium, and chloride.

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.

Cathode ray tube display system encoders and decoders have same MAC address; new system setup with two or more affected units can lead to systems not functioning reliably:audio, video and/or control signals might be interrupted or fall away, displays might switch to failover and back multiple times, devices/sources/sinks might not be discovered/available, might lead to delayed/prolonged procedures

Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user cannot enter a decimal separator in any manual entry screen if the user manually updates their phone settings to a region OUS that uses a decimal separator instead of a period decimal separator or chooses that format as a preference. Use of the affected software may result in over delivery of insulin by increasing the amount of insulin when a decimal separator is not recognized (e.g., 0.1 unit recognized as 1 unit) and thus may result in hypoglycemia, potentially severe.

Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).

Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in having to be replaced.

Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will gradually decrease to the point where the device alarms to indicate low oxygen purity will be incorrect.

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.

The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond exactly to the labeling stipulated by the FDA / CDRH.

A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.

Potential presence of residual adhesive material on the mesh surface.

Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%

Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death.

Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death.

The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond exactly to the labeling stipulated by the FDA / CDRH.

Potential presence of residual adhesive material on the mesh surface.

Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).

Potential presence of residual adhesive material on the mesh surface.