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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
Patient monitor has nine identified cybersecurity vulnerabilities.
Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. The remaining three (3) with tumor profiling result changes did not impact CDx indications.
Three is the potential for the retractors to puncture through the sterile packaging.
The high voltage capacitor may fail early in the product life cycle after delivery of surge voltages. When this failure occurs, the capacitor may produce smoke and a burning smell. In extremely rare instances a capacitor may cause a spark or excessive heat when an internal capacitor failure occurs.
Thrombectomy device specifies vessel range of 2.5-6 mm on the pouch, carton, and Instructions for Use rather than the correct vessel range of 3-6 mm, which could incrementally increase the radial force on the artery, which has the potential of vascular complications.
Due to a software issue, the software may incorrectly process the date of birth (DoB) received from the Laboratory Information System (LIS) and when the DoB is set to 01/01/1900 or left empty, REMISOL Advance may incorrectly identify a patient as a newborn, affecting the execution of validation rules based on incorrect reference ranges. The test results are not changed by this software defect and are accurately displayed by REMISOL Advance; however, the evaluation flagging of the results may be affected. This issue may lead to wrong reference range calculations and can result in erroneous flagged results being auto validated and uploaded to LIS.
Incorrect labeling in which the front red pouch label did not match the actual size of the medical device. The label on the front of the scope incorrectly states 5.0/2.2 while the back label, shipping box and product inside correctly states 5.6/2.8.
A cybersecurity vulnerability was discovered through internal testing.
Vials of implant bone granules may contain less product then specified on labeling.
A cybersecurity vulnerability was discovered through internal testing.
Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.
Apic Yamada has recently discovered that certain products may be out of compliance with FDA electronic product regulations in that they did not bear a required label.
Potential for internal fastening mechanism within generator of mobile x-Ray to fail.
Potential for microbial contamination.
Potential for microbial contamination.
Preset treatment parameters are not consistently being used in accordance with the IFU.
Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.