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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical supplied finished kits. Merit Medical supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
LIH Influence check settings for Lipemia are incorrect which may result patient samples being reported as false low results or cause a high result to report as normal
During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number.
Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set lnvalid, may result in a delay of surgery
Due to modified test kits being marketed and distributed without FDA Approval, Clearance or Authorization.
The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments.
The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments.
After surgery initiation, while using surgical image guidance, if significant eye rotation/movement occurs, a software anomaly may cause re-establishment of incorrect new registration angle, range indicator will display incorrectly, which could result in incorrect placement of toric IOL axis, which could cause astigmatic error under/over correction resulting in decreased uncorrected visual acuity.
Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique
When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) and is running with the system software versions 1.17.0 and below, the analyzer does not send a message to the LAS when the sample wheel is full, and the LAS continues sending samples despite the limited capacity to process new samples. Therefore, sample tests may be aliquoted but not processed when the number of tests associated with onboard patient samples exceeds the throughput limit. If this issue occurs test results are flagged with a sample wheel timeout (SWT) error flag, and there may be a delay in reporting test results which could lead to a delay in patient treatment.
Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may cause users to over-tightening the luer which may result in the swivel nut detaching from the HVA body.
Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS); is running with the software versions 1.17 and below; and a sample tube is sent from the LAS to DxI 9000 Access Immunoassay Analyzer, an out of sequence message will be sent from the Analyzer to the LAS. This issue may result in multiple error messages (i.e., a sample pick and place (PnP) error or a no result obtained (NRT) flag may be displayed) and subsequently a risk of delays in processing/reporting patient test results and patient treatment.
Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
Due to a component change, the console part of a circulatory support system may not conform to the IEC 61000-4-5 standard, so if subjected to a power surge above 1.8kV and up to 2.0 kV, the console may shut down completely without alarm, pumping would cease, and the patient would have to be switched to a backup circulatory support system.
Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique
Potential for inaccurate fetal heart rate measurements when monitoring multiples.