Florida recalls

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

There is the potential for leakage along the drug pathway from the pump through the end of the catheter.

Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system.

Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.

During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.

During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.

During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.

Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for destruction because the G7 sensors were not properly sterilized and have an increased risk of skin infection if used. Lot 1725069002 were designated for destruction due to an increased risk of having no sensor readings available or experiencing sensor inaccuracy that includes the potential for missed detection of a hyperglycemic event or incorrect treatment decisions that can result in patient injury, including medical intervention to prevent permanent injury or impairment. Additionally, due to the unknown storage and handling and storage conditions these sensors may have undergone during the distribution, these sensors may present additional risk.

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Software anomaly that causes a false display of error code 5018.

GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches an interactive application (e.g. Volume Viewer), the application may open the previous patient's exam instead of the intended one. When this issue occurs, there is no system warning or error notification. If the error is not recognized, a clinical user could review, interpret, or report images for the wrong patient which could lead to misdiagnosis, incorrect clinical decisions, resulting in delayed or incorrect treatment.

Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical intervention if the procedure must be completed with an alternative technique.