Oregon recalls

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.

Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the biocompatibility requirements for in-vitro-cytotoxicity, which if in contact with a patient's vasculature could result in localized inflammation and tissue irritation.

Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of backup power sources, which may result in delayed caregiver awareness of a hazardous condition.

Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.

Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.

Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.

Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding.

The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.

The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.

The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.

The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.

Undeclared allergens: Milk and Soy

Potential presence of Salmonella.

Potential presence of Salmonella.

Potential presence of Salmonella.

Potential presence of Salmonella.